Frequen-ZZZ SleepPad Investigational Device POC

December 12, 2024 updated by: Kunasan Inc.

Use of the Frequen-ZZZ Sleep Pad to Increase Restorative Sleep: A Proof-of-Concept Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Anne-Marie Chang, Ph.D.
  • Phone Number: 814-863-5226
  • Email: amchang@psu.edu

Study Contact Backup

  • Name: Margeaux M Schade (Gray), Ph.D.
  • Phone Number: 484-336-3064
  • Email: mmg58@psu.edu

Study Locations

  • United States
    • Pennsylvania
      • State College, Pennsylvania, United States, 16802
        • The Pennsylvania State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Sleep Architecture
Time Frame: 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).

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
Time Frame: 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).

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kunasan Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kunasan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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