Insomnia, Primary
Conditions
Brief summary
Participants will be recruited and screened through ongoing studies in the sleep and anxiety disorders clinic. Participants with insomnia will be consented to complete several questionnaires, undergo a brief physical exam, provide a urinalysis, and undergo 5 nights of active or sham Low Field Magnetic Stimulation (LFMS) followed by an overnight sleep study. Each of the two treatment conditions (active versus sham) will be conducted on two consecutive nights. There will be no more than 7 days between the adaptation night and the first treatment condition and no more than 7 nights between each of the two-night treatment conditions . Thus, each participant who completes the full study will spend a total of 5 nights in the sleep laboratory and the time interval from the first adaptation night to completion of the study may range from 5-19 days for any particular individual.
Interventions
DEVICELFMS - Active
A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
DEVICELFMS - Sham
A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
Sponsors
Tal Medical, Inc.
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Insomnia diagnosis per DSM-5 criteria * Performing tasks in a timely manner (compared to the person's usual level of performance) * Pittsburgh Sleep Quality Index (PSQI) \> 6 and one of the following: * Sleep Efficiency \< 85% (per Consensus Sleep Diary) * Insomnia Severity Index (ISI) score \> 15 * Sleep latency (subjective) and/or time awake after sleep onset (subjective) \>30 minutes. * Not currently depressed (previous major depressive episodes and current antidepressant medication permitted as long as remission and current medication dosage has been stable for ≥ 1 month). * Willing to refrain from alcohol for twenty-four hours before presenting to sleep lab for sleep studies * BMI \> 18 and \< 50 kg/m2
Exclusion criteria
* Current major depressive episode * Current substance-induced depressive disorder * Self-reported use of benzodiazepines or hypnotic drugs in last two weeks * Self-reported use of marijuana in previous 72 hours * Alcohol Use Disorders Identification Test (AUDIT) score \> 10 * Fagerstrom Test for Nicotine Dependence (FTND) score \> 4 * Insomnia limited to early morning awakening (without difficulty initiating or maintaining sleep), * Narcolepsy * Seizure Disorder (not including childhood febrile seizures) * Recent treatment with anticonvulsant medications * Obstructive or central sleep apnea * Circadian rhythm sleep-wake disorders * Recurrent isolated sleep paralysis * Current substance-induced insomnia * Chronic pain disorder * Daily Caffeine Consumption \> 500 mg/d (Uhde, 1989) * Restless legs syndrome * Periodic Leg Movement Disorder * Benzodiazepines or antipsychotic medications during past 30 days * Presence of drugs of abuse (excluding marijuana, urinalysis) * Pregnancy or plans to become pregnant * History of severe allergic reactions to adhesive tape * History of neurological disorder * Conductive, ferromagnetic or other magnetic-sensitive metals in the head, neck, chest, upper arms, or any area that will be within 18 inches of the treatment coil.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | MUSC Sleep Quality Score (SQS) is assessed after each night as a subjective measure; participants self-rate their perceived sleep quality on a 0-6 scale where 0 is associated with extremely poor sleep quality and 6 is associated with extremely good sleep quality. |
| Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG). |
| Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | Sleep Efficiency (SE) is an objective measure of sleep quality derived from polysomnography (PSG); it is a unitless measure defined as the total sleep time (TST) divided by total time in bed (TiB); it can theoretically range from 0 (no sleep at all) to 1 (slept the entire time in bed). Values close to zero indicate very little time spent sleeping while values close to one indicate a large sleep utilization while in bed. |
| Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | Ease of Sleep (EOS) is assessed after each night as a subjective measure; participants self-rate their ease to fall asleep on a visual analog scale 0-100mm where 0mm is associated with not easy at all (no sleep) and 100mm is associated with no problems to fall asleep. EOS is a proxy measure for a participants sleepiness. |
| Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | SOL is the time of transition from wake to sleep (non-REM S1) measured in minutes; a validated objective measure extracted directly from full-night polysomnography (PSG). SOL of 0-5min is associated with severe sleep deprivation; 5-10min is moderate sleep debt; 10-15min indicates mild sleep debt; 15-20min is little-to-no sleep debt; and \>20min is considered to be associated with no sleep debt. |
| Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | Total time awake after initial sleep onset in minutes; validated objective measure directly extracted from polysomnography (PSG); we average measures from both consecutive nights under each of the two interventions (Sham or Active LFMS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. |
| Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | Participants rate after each night their ability to concentrate on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. This is a subjective proxy measure for a restorative sleep / sleep quality. |
| Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS | Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count. |
Countries
United States
Participant flow
Recruitment details
Eligibility screening was completed over the phone by trained sleep personnel; sleep laboratory is located at the Medical University of South Carolina's Institute of Psychiatry at 67 President St., Charleston S.C. This is a crossover study; each participant is exposed to both active and sham conditions.
Pre-assignment details
N=209 subjects screened from 07/2016-07/2017; N=193 participants were excluded prior to PSG because they declined to participate (N=49), did not meet the age criterion (N=28), did not meet the sleep criterion (N=61), had co-morbid psychiatric disorders (N=42), or for other reasons (N=13); N=4 excluded after consent due to medication/baby/no-show.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants are randomized to receive either two consecutive nights of Active Low Field Magnetic Stimulation followed by Sham Low Field Magnetic Stimulation or vice versa.
Active Low Field Magnetic Stimulation LFMS - Active: A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
Sham Low Field Magnetic Stimulation LFMS - Sham: A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes) | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Adaptation Night (Night #1 PSG) | Adverse Event | 1 | 0 |
| Second Intervention (Nights #4 and #5) | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 35.58 years STANDARD_DEVIATION 8.512 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 67.83 inch STANDARD_DEVIATION 3.54 |
| PSQI (Pittsburgh Sleep Quality Inventory) | 11.58 units on a scale STANDARD_DEVIATION 2.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight | 184.83 lbm (pound mass) STANDARD_DEVIATION 35.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Ease of Sleep (EOS) is assessed after each night as a subjective measure; participants self-rate their ease to fall asleep on a visual analog scale 0-100mm where 0mm is associated with not easy at all (no sleep) and 100mm is associated with no problems to fall asleep. EOS is a proxy measure for a participants sleepiness.
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 51.95 units on a scale (0-100mm) | Standard Deviation 26.47 |
| Active Low Field Magnetic Stimulation | Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline EOS | 63.30 units on a scale (0-100mm) | Standard Deviation 30.99 |
| Active Low Field Magnetic Stimulation | Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline EOS | -11.35 units on a scale (0-100mm) | Standard Deviation 25.7 |
| Sham Low Field Magnetic Stimulation | Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline EOS | 63.30 units on a scale (0-100mm) | Standard Deviation 30.99 |
| Sham Low Field Magnetic Stimulation | Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 47.70 units on a scale (0-100mm) | Standard Deviation 17.76 |
| Sham Low Field Magnetic Stimulation | Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline EOS | -15.60 units on a scale (0-100mm) | Standard Deviation 26.17 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differp-value: 0.535t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.196t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.092t-test, 2 sided
Primary
MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
MUSC Sleep Quality Score (SQS) is assessed after each night as a subjective measure; participants self-rate their perceived sleep quality on a 0-6 scale where 0 is associated with extremely poor sleep quality and 6 is associated with extremely good sleep quality.
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline SQS | 1.90 score on a scale (0-6) | Standard Deviation 0.74 |
| Active Low Field Magnetic Stimulation | MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 2.75 score on a scale (0-6) | Standard Deviation 0.82 |
| Active Low Field Magnetic Stimulation | MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline SQS | 0.85 score on a scale (0-6) | Standard Deviation 0.71 |
| Sham Low Field Magnetic Stimulation | MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline SQS | 1.90 score on a scale (0-6) | Standard Deviation 0.74 |
| Sham Low Field Magnetic Stimulation | MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 2.75 score on a scale (0-6) | Standard Deviation 1.25 |
| Sham Low Field Magnetic Stimulation | MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline SQS | 0.85 score on a scale (0-6) | Standard Deviation 1.13 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differp-value: 1t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.004t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.042t-test, 2 sided
Primary
Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Sleep Efficiency (SE) is an objective measure of sleep quality derived from polysomnography (PSG); it is a unitless measure defined as the total sleep time (TST) divided by total time in bed (TiB); it can theoretically range from 0 (no sleep at all) to 1 (slept the entire time in bed). Values close to zero indicate very little time spent sleeping while values close to one indicate a large sleep utilization while in bed.
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline SE | 0.72 unitless ratio (0 to 1) | Standard Deviation 0.16 |
| Active Low Field Magnetic Stimulation | Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 0.77 unitless ratio (0 to 1) | Standard Deviation 0.11 |
| Active Low Field Magnetic Stimulation | Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline SE | 0.05 unitless ratio (0 to 1) | Standard Deviation 0.11 |
| Sham Low Field Magnetic Stimulation | Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline SE | 0.72 unitless ratio (0 to 1) | Standard Deviation 0.16 |
| Sham Low Field Magnetic Stimulation | Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 0.79 unitless ratio (0 to 1) | Standard Deviation 0.08 |
| Sham Low Field Magnetic Stimulation | Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline SE | 0.07 unitless ratio (0 to 1) | Standard Deviation 0.15 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differp-value: 0.424t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.21t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.19t-test, 2 sided
Primary
Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
SOL is the time of transition from wake to sleep (non-REM S1) measured in minutes; a validated objective measure extracted directly from full-night polysomnography (PSG). SOL of 0-5min is associated with severe sleep deprivation; 5-10min is moderate sleep debt; 10-15min indicates mild sleep debt; 15-20min is little-to-no sleep debt; and \>20min is considered to be associated with no sleep debt.
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Intervention LFMS; two-night average in each arm | 53.88 minutes | Standard Deviation 40.03 |
| Active Low Field Magnetic Stimulation | Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline SOL | 43.35 minutes | Standard Deviation 25.95 |
| Active Low Field Magnetic Stimulation | Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline SOL | 10.53 minutes | Standard Deviation 31.67 |
| Sham Low Field Magnetic Stimulation | Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Intervention LFMS; two-night average in each arm | 46.35 minutes | Standard Deviation 34.5 |
| Sham Low Field Magnetic Stimulation | Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline SOL | 43.35 minutes | Standard Deviation 25.95 |
| Sham Low Field Magnetic Stimulation | Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline SOL | 3.00 minutes | Standard Deviation 22.77 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differp-value: 0.329t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.321t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.687t-test, 2 sided
Primary
Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG).
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline TST | 359.60 minutes | Standard Deviation 86.6 |
| Active Low Field Magnetic Stimulation | Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 370.40 minutes | Standard Deviation 80.96 |
| Active Low Field Magnetic Stimulation | Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline TST | 10.80 minutes | Standard Deviation 60.5 |
| Sham Low Field Magnetic Stimulation | Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline TST | 359.60 minutes | Standard Deviation 86.6 |
| Sham Low Field Magnetic Stimulation | Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 388.53 minutes | Standard Deviation 73.02 |
| Sham Low Field Magnetic Stimulation | Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline TST | 28.93 minutes | Standard Deviation 82.73 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differp-value: 0.197t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.586t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.298t-test, 2 sided
Primary
Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Total time awake after initial sleep onset in minutes; validated objective measure directly extracted from polysomnography (PSG); we average measures from both consecutive nights under each of the two interventions (Sham or Active LFMS)
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 54.80 minutes | Standard Deviation 46.87 |
| Active Low Field Magnetic Stimulation | Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline WASO | 26.05 minutes | Standard Deviation 41.69 |
| Active Low Field Magnetic Stimulation | Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline WASO | 80.85 minutes | Standard Deviation 78.41 |
| Sham Low Field Magnetic Stimulation | Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 56.00 minutes | Standard Deviation 31.31 |
| Sham Low Field Magnetic Stimulation | Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline WASO | 24.85 minutes | Standard Deviation 59.75 |
| Sham Low Field Magnetic Stimulation | Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline WASO | 80.85 minutes | Standard Deviation 78.41 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differp-value: 0.925t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.08t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.221t-test, 2 sided
Secondary
Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Participants rate after each night their ability to concentrate on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. This is a subjective proxy measure for a restorative sleep / sleep quality.
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline concentration | 46.80 units on a scale (0-100mm) | Standard Deviation 22.42 |
| Active Low Field Magnetic Stimulation | Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 42.40 units on a scale (0-100mm) | Standard Deviation 19.58 |
| Active Low Field Magnetic Stimulation | Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline concentration | -4.40 units on a scale (0-100mm) | Standard Deviation 11.28 |
| Sham Low Field Magnetic Stimulation | Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline concentration | 46.80 units on a scale (0-100mm) | Standard Deviation 22.42 |
| Sham Low Field Magnetic Stimulation | Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 36.80 units on a scale (0-100mm) | Standard Deviation 20.37 |
| Sham Low Field Magnetic Stimulation | Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline concentration | -10.00 units on a scale (0-100mm) | Standard Deviation 18.09 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differp-value: 0.13t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.249t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.114t-test, 2 sided
Secondary
Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot.
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline fatigue | 58.10 units on a scale (0-100mm) | Standard Deviation 24.73 |
| Active Low Field Magnetic Stimulation | Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 52.65 units on a scale (0-100mm) | Standard Deviation 22.3 |
| Active Low Field Magnetic Stimulation | Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline fatigue | -5.45 units on a scale (0-100mm) | Standard Deviation 11.13 |
| Sham Low Field Magnetic Stimulation | Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline fatigue | 58.10 units on a scale (0-100mm) | Standard Deviation 24.73 |
| Sham Low Field Magnetic Stimulation | Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 45.45 units on a scale (0-100mm) | Standard Deviation 27.58 |
| Sham Low Field Magnetic Stimulation | Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline fatigue | -12.65 units on a scale (0-100mm) | Standard Deviation 23.9 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differp-value: 0.226t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.156t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.117t-test, 2 sided
Secondary
Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)
Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count.
Time frame: Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS
Population: 12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 \& 4/5, each pair either sham or active.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Low Field Magnetic Stimulation | Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline #awake | 19 awakenings | Standard Deviation 8.31 |
| Active Low Field Magnetic Stimulation | Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 17.45 awakenings | Standard Deviation 5.36 |
| Active Low Field Magnetic Stimulation | Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline #awake | -1.55 awakenings | Standard Deviation 5.3 |
| Sham Low Field Magnetic Stimulation | Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Baseline #awake | 19 awakenings | Standard Deviation 8.31 |
| Sham Low Field Magnetic Stimulation | Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Sham or Active LFMS (two-night average) | 21.17 awakenings | Standard Deviation 8.31 |
| Sham Low Field Magnetic Stimulation | Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night) | Change from Baseline #awake | 2.50 awakenings | Standard Deviation 6.53 |
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differp-value: 0.05t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.379t-test, 2 sided
Comparison: This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zerop-value: 0.284t-test, 2 sided