Insomnia, Sleep, Sleep Disturbance
Conditions
Brief summary
The investigators propose to examine the potential effects of the Frequen- ZZZ sleep pad - a noninvasive, unobtrusive appliance that generates a localized low-level electromagnetic field via radiofrequency, and that is used on the bed - on multiple sleep outcomes in an 8-week randomized crossover study, and to calculate the effect sizes of the intervention to inform power and sample size for future studies.
Detailed description
This research is a small, 8wk clinical trial testing the potential effects of an investigational device, Frequen-ZZZ Sleep Pad, on the sleep of adults 40-65 years old. The investigators aim to determine whether sleeping with the Sleep Pad, which creates a radio-frequency field around the sleeper, improves sleep. Sleep will be primarily measured using a noninvasive clinical standard method, called polysomnography (PSG), for 6 separate nights in the personal residence of participants. Sleep will also be measured both day and night with a watch-like device that measures activity, and with surveys. The investigators will look for changes in sleep quality, in sleep duration, and in the way that sleep is organized by the body (sleep architecture). There are 12-15 in-person appointments across the course of the study. With the data, the investigators hope to also evaluate the feasibility and effect sizes of this non-pharmacological intervention to inform future research, and plan to use data in support of a future FDA application for the device.
Interventions
DEVICEActivated Sleep Pad system (Frequen-ZZZ)
The investigational device is a sleep pad and bedside controller system capable of producing a low-level radio-frequency field potential. An individual laying in the correct orientation and with correct contact distance from the pad portion of a powered device experiences its specific area of effect. The field potentials generated by the pad are hypothesized to have benefit for sleep.
DEVICEDeactivated Sleep Pad system (Frequen-ZZZ)
The investigational device is a sleep pad and bedside controller system that produces a low-level radio-frequency field potential. An individual laying in the correct orientation and with correct contact distance from the pad portion of a non-powered device experiences all functional aspects of the device except the intended magnetic field potential that is hypothesized to have benefit for sleep.
Sponsors
Penn State University
Kunasan Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This study is a double-blind trial, in which bedside controllers for Sleep Pad systems are coded and either activated or deactivated (sham/control) by the manufacturer prior to receipt for use in the research. A deactivated Sleep Pad bedside controller retains all functionality (and evidence of functionality) of an activated bedside controller Sleep Pad, excepting the stimulation. The blind is maintained by a designated study team member who will have access to the list linking device code IDs to their relative active/sham group, and who does not have interaction with study participants. This blind will be lifted if relevant for safety reasons in cases of serious adverse event on a participant case-by-case basis, and on the whole for other researchers after completion of the entire trial for interpretation of analyses.
Intervention model description
All participants in this study will experience all study conditions (i.e. a sham (Control) and an active (Intervention) Sleep Pad bedside controller device) in a randomized crossover design.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent is obtained from the subject. 2. Subject is an English speaker and reader. They are able to understand the procedures related to the study. 3. Subject is 40-65 years of age at enrollment (by self report at Screening & verified with photo ID at full Consent) 4. Subject is not engaged in rotating or nocturnal shift employment (by self-report at Screening) 5. Subject is living independently (by self-report and/or according to their status at a community living facility) 6. Subject's personal residence is equipped with functional WiFi and subject is willing to permit study device connection to their WiFi (by self-report at Screening) 7. Insomnia Severity Index score of ≥8 at enrollment (based on self-administration at screening) 8. Willing to refrain from initiating new, sleep-directed interventions (e.g. medication; behavioral) that are not a part of this study protocol for the duration of study participation (by self-report) 9. Willing to refrain from all nicotine use for the duration of participation (by self-report) 10. Willing to refrain from pet access to the bed or sleeping space for the duration of participation (by self-report) 11. Regularly sleeping on a non-water bed (by self-report) 12. Has and uses own smart phone or tablet device, and is willing to continue to use personal device daily for study purposes (by self-report)
Exclusion criteria
1. Diagnosed with a sleep disorder (by self-report) 2. Has an implanted medical device (e.g., pacemaker, cochlear; by self-report) 3. Diagnosed serious mental/neurologic health disorder or substance use disorder (e.g., autism, psychosis, depression/bipolar, dementia; by self-report) 4. Personal health history of epilepsy or traumatic brain injury (by self-report) 5. Taking any physician-directed pharmacologic intervention for sleep or actively engaged in a clinically-validated course of therapy (including behavioral therapy for sleep; by self-report) 6. Diagnosed hydration problems or taking prescribed diuretic medication (by self-report) 7. Pregnant, breast-feeding, or planning to become pregnant during the study participation period (by self-report) 8. History of negative reaction to acupuncture (by self-report) 9. Recreational use of illicit substances in the past month (by self-report) 10. Any nicotine use in the past 3 months (by self-report) 11. History of sensitivity to, or considers oneself to be uniquely sensitive to, radio-frequency (by self-report) 12. Was previously engaged in this research as a randomized participant 13. If a participant does not live within a reasonable commutable distance from the Penn State University - University Park campus (i.e. \ 20min) to accommodate off-site study visits, then they must be willing to accept the costs and responsibilities of coming to campus (15-17 visits) in order to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Architecture | The later viable night of two recordings: At the end of Phase 1 - Week 2 or Phase 1 - Week 3, and At the end of Phase 2 - Week 2 or Phase 2 - Week 3. Sleep stage minutes (relative to Latency to Persistent Sleep, Edinger et al. 2013). | Quantity of each sleep stage defined by the American Academy of Sleep Medicine (NREM1, NREM2, NREM3, and REM), measured by clinically standard elements of Polysomnography and scored by a Registered Polysomnographic Technologist. Note: Randomization to Active or Sham during Phase 1 or Phase 2 occurred at the end of Baseline week. |
| Change in Insomnia Symptoms | Sum ISI score near end of Phase 1 (study wks2-4) and near end of Phase 2 (study wks6-8). | Self-reported score on the Insomnia Severity Index (ISI; 0-28) e-survey, where a higher score indicates worse/more Insomnia symptoms. |
Countries
United States
Participant flow
Recruitment details
Convenience sample of 40-65y/o with evidence of Insomnia symptoms in the State College, PA region.
Pre-assignment details
Demonstrated adherence to study procedures (surveys & actigraphy worn) during Baseline (Wk 1)
Participants by arm
| Arm | Count |
|---|---|
| Active Device Phase 1, Then Sham Device Phase 2 Wks 2-5 Active Device, then Wks 6-8 Sham Device | 5 |
| Sham Device Phase 1, Then Active Device Phase 2 Wks 2-5 Sham Device, then Wks 6-8 Active Device | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Sham Device Phase 1, Then Active Device Phase 2 | Total | Active Device Phase 1, Then Sham Device Phase 2 |
|---|---|---|---|
| Age, Continuous | 55.1 Years STANDARD_DEVIATION 8.5 | 55.2 Years STANDARD_DEVIATION 6 | 55.4 Years STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Insomnia Severity Index (ISI) | 12.4 Overall sum score STANDARD_DEVIATION 3.3 | 11.0 Overall sum score STANDARD_DEVIATION 4.3 | 9.6 Overall sum score STANDARD_DEVIATION 5.2 |
| Non-Rapid Eye Movement Stage 1 (NREM1) minutes | 92.3 Minutes STANDARD_DEVIATION 61.9 | 77.0 Minutes STANDARD_DEVIATION 45.6 | 61.6 Minutes STANDARD_DEVIATION 16.1 |
| Non-Rapid Eye Movement Stage 1 (NREM1) percentage | 21.7 % of Total Sleep STANDARD_DEVIATION 13.3 | 19.4 % of Total Sleep STANDARD_DEVIATION 10 | 17.0 % of Total Sleep STANDARD_DEVIATION 5.8 |
| Non-Rapid Eye Movement Stage 2 (NREM2) minutes | 193.5 Minutes STANDARD_DEVIATION 20.9 | 191.9 Minutes STANDARD_DEVIATION 40 | 190.2 Minutes STANDARD_DEVIATION 56.2 |
| Non-Rapid Eye Movement Stage 2 (NREM2) percentage | 47.4 % of Total Sleep STANDARD_DEVIATION 8.3 | 48.7 % of Total Sleep STANDARD_DEVIATION 8.1 | 49.9 % of Total Sleep STANDARD_DEVIATION 8.5 |
| Non-Rapid Eye Movement Stage 3 (NREM3) minutes | 29.1 Minutes STANDARD_DEVIATION 30.9 | 24.7 Minutes STANDARD_DEVIATION 25.8 | 20.2 Minutes STANDARD_DEVIATION 22.2 |
| Non-Rapid Eye Movement Stage 3 (NREM3) percentage | 7.2 % of Total Sleep STANDARD_DEVIATION 7.5 | 6.21 % of Total Sleep STANDARD_DEVIATION 6.26 | 5.2 % of Total Sleep STANDARD_DEVIATION 5.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 5 Participants |
| Rapid Eye Movement (REM) minutes | 98.0 Minutes STANDARD_DEVIATION 23.2 | 100.5 Minutes STANDARD_DEVIATION 19.6 | 102.9 Minutes STANDARD_DEVIATION 17.6 |
| Rapid Eye Movement (REM) percentage | 23.7 % of Total Sleep STANDARD_DEVIATION 4.7 | 25.8 % of Total Sleep STANDARD_DEVIATION 5.5 | 27.9 % of Total Sleep STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 5 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Insomnia Symptoms
Self-reported score on the Insomnia Severity Index (ISI; 0-28) e-survey, where a higher score indicates worse/more Insomnia symptoms.
Time frame: Sum ISI score near end of Phase 1 (study wks2-4) and near end of Phase 2 (study wks6-8).
Population: In this repeated-measures design, one participant had missing data for an Insomnia Severity Index (ISI) measure. Therefore, the analyzed sample for ISI Outcome is n=9 (5 Active Device Phase 1, then Sham; + 4 Sham Device Phase 1, then Active), rather than n=10.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Change in Insomnia Symptoms | 7.3 Sum score, on a scale of 0-28 | Standard Deviation 4.4 |
| Sham Device | Change in Insomnia Symptoms | 6.8 Sum score, on a scale of 0-28 | Standard Deviation 5 |
Comparison: Group Selection refers to study device Condition (Active/Sham); repeated-measures design.
Primary
Change in Sleep Architecture
Quantity of each sleep stage defined by the American Academy of Sleep Medicine (NREM1, NREM2, NREM3, and REM), measured by clinically standard elements of Polysomnography and scored by a Registered Polysomnographic Technologist. Note: Randomization to Active or Sham during Phase 1 or Phase 2 occurred at the end of Baseline week.
Time frame: The later viable night of two recordings: At the end of Phase 1 - Week 2 or Phase 1 - Week 3, and At the end of Phase 2 - Week 2 or Phase 2 - Week 3. Sleep stage minutes (relative to Latency to Persistent Sleep, Edinger et al. 2013).
Population: The same 10 (total) participants are represented in Arm/Group (repeated-measures).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Device | Change in Sleep Architecture | NREM1 | 48.8 Minutes | Standard Deviation 23.5 |
| Active Device | Change in Sleep Architecture | NREM2 | 212.5 Minutes | Standard Deviation 37.8 |
| Active Device | Change in Sleep Architecture | NREM3 | 32.85 Minutes | Standard Deviation 25.8 |
| Active Device | Change in Sleep Architecture | REM | 88.5 Minutes | Standard Deviation 32.7 |
| Sham Device | Change in Sleep Architecture | REM | 108.9 Minutes | Standard Deviation 38.6 |
| Sham Device | Change in Sleep Architecture | NREM1 | 54.0 Minutes | Standard Deviation 36.4 |
| Sham Device | Change in Sleep Architecture | NREM3 | 22.85 Minutes | Standard Deviation 17 |
| Sham Device | Change in Sleep Architecture | NREM2 | 218.7 Minutes | Standard Deviation 40.5 |
Comparison: Comparison for NREM1 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design
Comparison: Comparison for NREM2 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.
Comparison: Comparison for NREM3 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.
Comparison: Comparison for REM minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.
Primary
Change in Sleep Architecture
Percentage of each sleep stage defined by the American Academy of Sleep Medicine (NREM1, NREM2, NREM3, and REM), measured by clinically standard elements of Polysomnography and scored by a Registered Polysomnographic Technologist. Note: Randomization to Active or Sham during Phase 1 or Phase 2 occurred at the end of Baseline week.
Time frame: The later viable night of two recordings: At the end of Phase 1 - Week 2 or Phase 1 - Week 3, and At the end of Phase 2 - Week 2 or Phase 2 - Week 3. Sleep stage percentage (relative to Latency to Persistent Sleep, Edinger et al. 2013).
Population: The same 10 (total) participants are represented in Arm/Group (repeated-measures)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Device | Change in Sleep Architecture | NREM1 | 12.8 % of total sleep | Standard Deviation 6.7 |
| Active Device | Change in Sleep Architecture | NREM2 | 55.5 % of total sleep | Standard Deviation 6.8 |
| Active Device | Change in Sleep Architecture | NREM3 | 9.0 % of total sleep | Standard Deviation 7.4 |
| Active Device | Change in Sleep Architecture | REM | 22.6 % of total sleep | Standard Deviation 6.3 |
| Sham Device | Change in Sleep Architecture | REM | 26.8 % of total sleep | Standard Deviation 9.6 |
| Sham Device | Change in Sleep Architecture | NREM1 | 13.0 % of total sleep | Standard Deviation 7.2 |
| Sham Device | Change in Sleep Architecture | NREM3 | 5.9 % of total sleep | Standard Deviation 4.5 |
| Sham Device | Change in Sleep Architecture | NREM2 | 54.3 % of total sleep | Standard Deviation 9.5 |
Comparison: Comparison for NREM1 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.
Comparison: Comparison for NREM2 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.
Comparison: Comparison for NREM3 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.
Comparison: Comparison for REM percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.