Frequen-ZZZ SleepPad Investigational Device POC

NCT ID: NCT05908344

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2024-05-10

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.

Conditions

Insomnia; Sleep; Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Activated Sleep Pad controller

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.

Group Type: EXPERIMENTAL

Activated Sleep Pad system (Frequen-ZZZ)

Intervention Type: 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.

Deactivated Sleep Pad controller

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.

Group Type: SHAM_COMPARATOR

Deactivated Sleep Pad system (Frequen-ZZZ)

Intervention Type: 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.

Interventions

Activated Sleep Pad system (Frequen-ZZZ)

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.

Intervention Type: DEVICE

Deactivated Sleep Pad system (Frequen-ZZZ)

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.

Intervention Type: 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

Kunasan Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Pennsylvania State University

State College, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Kunasan

Identifier Type: -

Identifier Source: org_study_id