Frequen-ZZZ SleepPad Investigational Device POC

NCT05908344 | Completed Results FDA Device

• 1 other identifier: Kunasan
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Sleep; Sleep Disturbance

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

• 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.

  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).

• 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.

  Sum ISI score near end of Phase 1 (study wks2-4) and near end of Phase 2 (study wks6-8).

Study Arms (2)

Activated Sleep Pad controller

EXPERIMENTAL

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)

Deactivated Sleep Pad controller

SHAM COMPARATOR

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)

Interventions

Activated Sleep Pad system (Frequen-ZZZ) DEVICE

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.

Activated Sleep Pad controller

Deactivated Sleep Pad system (Frequen-ZZZ) DEVICE

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.

Deactivated Sleep Pad controller

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kunasan Inc.: lead
• Penn State University: collaborator

Study Sites (1)

The Pennsylvania State University

State College, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

Enrollment in this small pilot study was predominantly female (8/10), limiting the extension of effect size findings to a broader population.

Results Point of Contact

• Title: Dr. Anne-Marie Chang
• Organization: The Pennsylvania State University

amchang@psu.edu

814-863-5226

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 18, 2023
• Study Start: July 21, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: December 16, 2024
• Results First Posted: December 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)