N/A
N=10
Frequen-ZZZ SleepPad Investigational Device POC
Insomnia · Sleep · Sleep Disturbance
Bottom Line
View on ClinicalTrials.gov: NCT05908344 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Sleep Architecture — 48.8; 54.0; 212.5; 218.7 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Activated Sleep Pad system (Frequen-ZZZ) (Device); Deactivated Sleep Pad system (Frequen-ZZZ) (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Kunasan Inc.
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sleep Architecture |
12.8; 13.0; 55.5; 54.3; 9.0; 5.9 | — |
| PRIMARY Change in Sleep Architecture |
12.8; 13.0; 55.5; 54.3; 9.0; 5.9 | — |
| PRIMARY Change in Insomnia Symptoms |
7.3; 6.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05908344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.