Frequen-ZZZ SleepPad Investigational Device POC

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of the Frequen-ZZZ Sleep Pad to Increase Restorative Sleep: A Proof-of-Concept Study

Conditions
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Insomnia, Sleep, Sleep Disturbance

Intervention / Treatment
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* Device: Activated Sleep Pad system (Frequen-ZZZ)
* Device: Deactivated Sleep Pad system (Frequen-ZZZ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent is obtained from the subject. Subject is an English speaker and reader. They are able to understand the procedures related to the study. Subject is 40-65 years of age at enrollment (by self report at Screening & verified with photo ID at full Consent) Subject is not engaged in rotating or nocturnal shift employment (by self-report at Screening) Subject is living independently (by self-report and/or according to their status at a community living facility) 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) Insomnia Severity Index score of ≥8 at enrollment (based on self-administration at screening) 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) Willing to refrain from all nicotine use for the duration of participation (by self-report) Willing to refrain from pet access to the bed or sleeping space for the duration of participation (by self-report) Regularly sleeping on a non-water bed (by self-report) 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: Diagnosed with a sleep disorder (by self-report) Has an implanted medical device (e.g., pacemaker, cochlear; by self-report) Diagnosed serious mental/neurologic health disorder or substance use disorder (e.g., autism, psychosis, depression/bipolar, dementia; by self-report) Personal health history of epilepsy or traumatic brain injury (by self-report) 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) Diagnosed hydration problems or taking prescribed diuretic medication (by self-report) Pregnant, breast-feeding, or planning to become pregnant during the study participation period (by self-report) History of negative reaction to acupuncture (by self-report) Recreational use of illicit substances in the past month (by self-report) Any nicotine use in the past 3 months (by self-report) History of sensitivity to, or considers oneself to be uniquely sensitive to, radio-frequency (by self-report) Was previously engaged in this research as a randomized participant 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated Sleep Pad controller<br>Treatment dosing is under participant control, by physical proximity/orientation to the Sleep Pad pad portion of the Sleep Pad system, and by a manually operated power button on an activated bedside controller portion of the Sleep Pad system. Dosing is pre-set at a stable level across all participants. Dosing occurs throughout a participant's typical nocturnal sleep period, nightly, unless manually paused by the participant. | Device: Activated Sleep Pad system (Frequen-ZZZ)<br>* 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.<br>|
| Sham Comparator: Deactivated Sleep Pad controller<br>Use of the Sleep Pad system is consistent with the Experimental arm, excepting that a deactivated bedside controller portion of the Sleep Pad system is used. | Device: Deactivated Sleep Pad system (Frequen-ZZZ)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change in PSG stage minutes between Baseline (week 1) and each study Condition (weeks 4 & 8, in randomized order) | 
| Change in Sleep Architecture | Proportion 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. | Change in PSG stage as a % of total nocturnal sleep time between Baseline (week 1) and each study Condition (weeks 4 & 8, in randomized order) | 
| Change in Insomnia Symptoms | Self-reported score on the Insomnia Severity Index (0-28) survey, where a higher score indicates worse/more Insomnia symptoms. | Change in score between Baseline (week 1) and each study Condition (weeks 4 & 8, in randomized order) |