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Frequen-ZZZ SleepPad Investigational Device POC

Primary Purpose

Insomnia, Sleep, Sleep Disturbance

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Activated Sleep Pad system (Frequen-ZZZ)

Deactivated Sleep Pad system (Frequen-ZZZ)

About this trial

This is an interventional other trial for Insomnia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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) 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; by self-report) Diagnosed hydration problems or taking prescribed diuretics (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) 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) History of sensitivity to, or considers oneself to be uniquely sensitive to, radiofrequency (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) Was previously engaged in this research as a randomized participant

Sites / Locations

The Pennsylvania State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Activated Sleep Pad controller

Deactivated Sleep Pad controller

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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 Insomnia Symptoms

Self-reported score on the Insomnia Severity Index (0-28) survey, where a higher score indicates worse/more Insomnia symptoms.

Secondary Outcome Measures

Full Information

NCT ID

NCT05908344

First Posted

June 1, 2023

Last Updated

August 11, 2023

Sponsor

Kunasan Inc.

Collaborators

Penn State University

1. Study Identification

Unique Protocol Identification Number

NCT05908344

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 21, 2023 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kunasan Inc.

Collaborators

Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 an electromagnetic field around the sleeper, has an improving effect on 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Sleep, Sleep Disturbance

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

ParticipantInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Activated Sleep Pad controller

Arm Type

Experimental

Arm Description

Arm Title

Deactivated Sleep Pad controller

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Activated Sleep Pad system (Frequen-ZZZ)

Intervention Description

The investigational device is a sleep pad and bedside controller system capable of producing a low-level magnetic field potential via radiofrequency. 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.

Intervention Type

Device

Intervention Name(s)

Deactivated Sleep Pad system (Frequen-ZZZ)

Intervention Description

The investigational device is a sleep pad and bedside controller system that produces a low-level magnetic field potential via radiofrequency. 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.

Primary Outcome Measure Information:

Title

Change in Sleep Architecture

Description

Time Frame

Change in PSG stage minutes between Baseline (week 1) and each study Condition (weeks 4 & 8, in randomized order)

Title

Change in Sleep Architecture

Description

Time Frame

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)

Title

Change in Insomnia Symptoms

Description

Self-reported score on the Insomnia Severity Index (0-28) survey, where a higher score indicates worse/more Insomnia symptoms.

Time Frame

Change in score between Baseline (week 1) and each study Condition (weeks 4 & 8, in randomized order)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne-Marie Chang, Ph.D.

Phone

814-863-5226

amchang@psu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Margeaux M Schade (Gray), Ph.D.

Phone

484-336-3064

mmg58@psu.edu

Facility Information:

Facility Name

The Pennsylvania State University

City

State College

State/Province

Pennsylvania

ZIP/Postal Code

16802

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne-Marie Chang, Ph.D.

Phone

814-863-5226

amchang@psu.edu

First Name & Middle Initial & Last Name & Degree

Margeaux M Schade (Gray), Ph.D.

Phone

484-336-3064

mmg58@psu.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Frequen-ZZZ SleepPad Investigational Device POC

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