Insomnia, Sleeplessness, Transient Insomnia
Conditions
Keywords
Electric Stimulation, Latency to Persistent Sleep (LPS), Transient Insomnia, Insomnia
Brief summary
The purpose of this study is to determine whether a small electrical current to the vestibular nerve (balance organ) will decrease the time it take for participants to fall asleep.
Detailed description
This 2 arm study will look at the proposed treatment (electrical stimulation of the vestibular nerve) versus a sham or placebo device. The effect of the device will be evaluated in a study that uses normal sleepers and advances them(puts them to bed 5-hours earlier than normal) to see if they fall asleep faster in one group or the other. Stimulation in the treated or sham group is only for the first hour after lights off.
Interventions
DEVICEElectric stimulation of the Vestibular Nerve - VirtuSom
This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes.
DEVICEElectric stim of the Vestibular Nerve - VirtuSom - SHAM
This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females, ages 21- 50 attempts will be made to enroll equal distributions of males and females * Able and willing to provide written informed consent * Self reported habitual bedtime between 2100 and 0100 hours, which does not vary by more than 1 hour at least 5 nights per week * Self reported 7.5-9 hrs. habitual sleep time * Able to commit to 9 hrs of sleep opportunity throughout the study, but especially for the 3 nights prior to their PSG * Pass Berlin questionnaire, i.e. low likelihood of sleep disordered breathing * No history or evidence of RLS(restless leg syndrome) /PLMS (periodic limb movement syndrome) /Narcolepsy, no non-respiratory related sleep disorders.
Exclusion criteria
* Regular use of a pack or more per day of tobacco products * Typically consumes more than 2 (12 oz) caffeinated beverages per day * Self reported history of motion sickness * Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study * Clinically significant medical or psychiatric condition as determined by the investigator * Probable diagnosis of a current sleep disorder including but not limited to insomnia, sleep apnea, restless legs syndrome, or periodic limb movement disorder * History of current or recent (e.g. within past 5 years) alcohol, narcotic or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV) * Currently works night shift or rotating shift * Travel or planned travel across more than 1 time zone within one week prior to randomization * Use of any medication that, in the opinion of the investigator, may alter sleep or wakefulness. (See Appendix E: Guideline For Medications Commonly Associated With Alterations Of Sleep / Wake Functioning). Subjects will undergo urine drug testing. * Consumption of more than 14 alcoholic drinks per week, or the recent consumption of more than 4 alcoholic drinks in one night. Subjects will be tested for alcohol, using a saliva test kit. * Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women's of child bearing age). * Presence of a pacemaker * Presence of epilepsy or other uncontrolled medical conditions. * Prior participation in a VirtuSom protocol * History of vestibular disorders, (such as vertigo)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency to Persistent Sleep (LPS) | Treatment Night | Latency to Persistent Sleep is how long does it take for a person to fall asleep and stay asleep. This is measured in minutes. This is different from sleep onset latency as participants fall asleep, but may wake back up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Sleep Onset Latency (SOL) | Treatment night | Subjective sleep onset latency is how long it took a person to fall asleep once lights out. For subjective SOL this is a question to a participant the next morning asking how long they felt it took them to fall asleep in minutes. |
| Total Sleep Time (TST) in the First 2 Hours After Lights Out | Treatment night | Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is for the 2 hours after lights out. |
| Total Sleep Time (TST) in the First Hour After Lights Out | Treatment night | Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is the total amount of sleep a participant gets over the first hour of sleep after lights out. |
| Scored Sleep Onset Latency (SOL on PSG) | Treatment Night | Sleep onset latency is the amount of time it takes to fall asleep after the lights have been turned off. For this outcome measure it is as measured by the scored PSG. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1- VirtuSom - Stim Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) \>=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).
Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. | 176 |
| Group 2- VirtuSom- Sham Normal sleepers (7.5 - 9.0 hours), MSLT \>=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).
Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only. | 173 |
| Total | 349 |
Baseline characteristics
| Characteristic | Group 2- VirtuSom- Sham | Total | Group 1- VirtuSom - Stim |
|---|---|---|---|
| Age, Continuous | 31.91 years STANDARD_DEVIATION 7.74 | 31.76 years STANDARD_DEVIATION 7.63 | 31.53 years STANDARD_DEVIATION 7.56 |
| Body Mass Index | 26.00 kg/m^2 STANDARD_DEVIATION 5.42 | 25.71 kg/m^2 STANDARD_DEVIATION 5.23 | 25.42 kg/m^2 STANDARD_DEVIATION 5.04 |
| Diastolic Blood Pressure | 72.84 mmHg STANDARD_DEVIATION 9 | 72.23 mmHg STANDARD_DEVIATION 8.94 | 71.62 mmHg STANDARD_DEVIATION 8.86 |
| Pulse | 69.43 beats per minute STANDARD_DEVIATION 9.6 | 69.79 beats per minute STANDARD_DEVIATION 9.79 | 70.14 beats per minute STANDARD_DEVIATION 9.99 |
| Region of Enrollment United States | 173 participants | 349 participants | 176 participants |
| Respiration | 16.82 breaths per minute STANDARD_DEVIATION 1.88 | 16.65 breaths per minute STANDARD_DEVIATION 2.05 | 16.49 breaths per minute STANDARD_DEVIATION 2.19 |
| Sex: Female, Male Female | 118 Participants | 237 Participants | 119 Participants |
| Sex: Female, Male Male | 55 Participants | 112 Participants | 57 Participants |
| Sleep Onset Latency on Multiple Sleep Latency Test | 17.93 minutes STANDARD_DEVIATION 1.81 | 17.86 minutes STANDARD_DEVIATION 1.86 | 17.79 minutes STANDARD_DEVIATION 1.9 |
| Systolic Blood Pressure | 115.64 mmHg STANDARD_DEVIATION 11.91 | 114.60 mmHg STANDARD_DEVIATION 12.18 | 113.57 mmHg STANDARD_DEVIATION 12.39 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 176 | 11 / 173 |
| serious Total, serious adverse events | 0 / 176 | 0 / 173 |
Outcome results
Primary
Latency to Persistent Sleep (LPS)
Latency to Persistent Sleep is how long does it take for a person to fall asleep and stay asleep. This is measured in minutes. This is different from sleep onset latency as participants fall asleep, but may wake back up.
Time frame: Treatment Night
Population: Only 282 of the Polysomnography results were scorable. 132 for the treatment (stim group) and 150 for the sham group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- VirtuSom - Stim | Latency to Persistent Sleep (LPS) | 48.14 minutes | Standard Deviation 70.41 |
| Group 2- VirtuSom- Sham | Latency to Persistent Sleep (LPS) | 58.84 minutes | Standard Deviation 87.03 |
p-value: 0.1275t-test, 1 sided
Secondary
Scored Sleep Onset Latency (SOL on PSG)
Sleep onset latency is the amount of time it takes to fall asleep after the lights have been turned off. For this outcome measure it is as measured by the scored PSG.
Time frame: Treatment Night
Population: It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- VirtuSom - Stim | Scored Sleep Onset Latency (SOL on PSG) | 27.50 minutes | Standard Deviation 49.79 |
| Group 2- VirtuSom- Sham | Scored Sleep Onset Latency (SOL on PSG) | 31.28 minutes | Standard Deviation 50.03 |
Secondary
Subjective Sleep Onset Latency (SOL)
Subjective sleep onset latency is how long it took a person to fall asleep once lights out. For subjective SOL this is a question to a participant the next morning asking how long they felt it took them to fall asleep in minutes.
Time frame: Treatment night
Population: Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.~Not all participants answered this question the following morning, participants analyzed is less
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- VirtuSom - Stim | Subjective Sleep Onset Latency (SOL) | 79.16 minutes | Standard Deviation 97.78 |
| Group 2- VirtuSom- Sham | Subjective Sleep Onset Latency (SOL) | 87.91 minutes | Standard Deviation 101.16 |
Secondary
Total Sleep Time (TST) in the First 2 Hours After Lights Out
Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is for the 2 hours after lights out.
Time frame: Treatment night
Population: It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- VirtuSom - Stim | Total Sleep Time (TST) in the First 2 Hours After Lights Out | 66.65 minutes | Standard Deviation 32.81 |
| Group 2- VirtuSom- Sham | Total Sleep Time (TST) in the First 2 Hours After Lights Out | 64.17 minutes | Standard Deviation 36.75 |
Secondary
Total Sleep Time (TST) in the First Hour After Lights Out
Total sleep time is the total amount of sleep a person gets in minutes over the course of the night. For this outcome measure it is the total amount of sleep a participant gets over the first hour of sleep after lights out.
Time frame: Treatment night
Population: It was noted on initial evaluation of the results, that Site 6 indicate that there are properties of either the population or the study site that make it different from the remaining sites. For this reason, the analysis of the primary and secondary endpoints of the trial were done with Site 6 excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1- VirtuSom - Stim | Total Sleep Time (TST) in the First Hour After Lights Out | 33.84 minutes | Standard Deviation 16.01 |
| Group 2- VirtuSom- Sham | Total Sleep Time (TST) in the First Hour After Lights Out | 30.51 minutes | Standard Deviation 18.15 |