Clinical trial NCT05908344: Frequen-ZZZ SleepPad Investigational Device POC
Official title: Use of the Frequen-ZZZ Sleep Pad to Increase Restorative Sleep: A Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep
Sleep Disturbance
Lead sponsor: Kunasan Inc.
Sponsor class: INDUSTRY
Collaborators: name: Penn State University
First posted: 2023-06-18
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sleep Architecture
timeFrame: 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).
measure: Change in Sleep Architecture
timeFrame: 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).
measure: Change in Insomnia Symptoms
timeFrame: Sum ISI score near end of Phase 1 (study wks2-4) and near end of Phase 2 (study wks6-8).
Secondary outcomes:
Other outcomes:
Locations:
city: State College
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References: