InsomniaNCT05908344

Frequen-ZZZ SleepPad Investigational Device POC

A study testing Activated Sleep Pad system (Frequen-ZZZ) and Deactivated Sleep Pad system (Frequen-ZZZ) in people with Insomnia and Sleep, run by Kunasan Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia, Sleep, Sleep Disturbance
What is being tested?: Activated Sleep Pad system (Frequen-ZZZ) and Deactivated Sleep Pad system (Frequen-ZZZ)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 21 Jul 2023to 10 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

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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)

Who cannot join

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)

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Pennsylvania State University
State College, Pennsylvania, 16802

Other trials in United States

About this study

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

Read the 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
Being tested: Activated Sleep Pad system (Frequen-ZZZ), Deactivated Sleep Pad system (Frequen-ZZZ)
Medical subject headings: Sleep Initiation and Maintenance Disorders, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT05908344
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Deactivated Sleep Pad system (Frequen-ZZZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 202310 May 2024

First posted18 Jun 2023
Study start21 Jul 2023
Primary completion10 May 2024
Study completion10 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05908344
Sponsor's protocol ID: Kunasan
Status last verified: May 2024
First submitted: 1 Jun 2023
Last updated: 16 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of the Frequen-ZZZ Sleep Pad to Increase Restorative Sleep: A Proof-of-Concept Study
ClinicalTrials.gov ID: NCT05908344
Acronym / sponsor ID: Kunasan
Conditions: Insomnia, Sleep, Sleep Disturbance
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Kunasan Inc.Industry (pharma, biotech, devices)
Collaborators: Penn State University
Study start: 21 Jul 2023 (actual)
Primary completion: 10 May 2024 (actual)
Study completion: 10 May 2024 (actual)
First posted: 18 Jun 2023 (actual)
Results: Posted 16 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Activated Sleep Pad controller	Experimental	Device: Activated Sleep Pad system (Frequen-ZZZ)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.
Deactivated Sleep Pad controller	Sham comparator	Device: Deactivated Sleep Pad system (Frequen-ZZZ)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.

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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)

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Activated Sleep Pad controller
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.	Device	Deactivated Sleep Pad controller

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 16 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Device in Phase 1, Then Sham Device in Phase 2	5	5
Sham Device in Phase 1, Then Active Device in Phase 2	5	5

Primary outcome: 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).. Mean (Standard Deviation). Unit: Minutes

Measure	Active Device n = 10	Sham Device n = 10
NREM1	48.8 (23.5)	54.0 (36.4)
NREM2	212.5 (37.8)	218.7 (40.5)
NREM3	32.85 (25.8)	22.85 (17.0)
REM	88.5 (32.7)	108.9 (38.6)

Active Device vs Sham Device: Cohen's d: -0.24
Active Device vs Sham Device: Cohen's d: -0.15
Active Device vs Sham Device: Cohen's d: 0.69

Population analysed: The same 10 (total) participants are represented in Arm/Group (repeated-measures).

Primary outcome: 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).. Mean (Standard Deviation). Unit: % of total sleep

Measure	Active Device n = 10	Sham Device n = 10
NREM1	12.8 (6.7)	13.0 (7.2)
NREM2	55.5 (6.8)	54.3 (9.5)
NREM3	9.0 (7.4)	5.9 (4.5)
REM	22.6 (6.3)	26.8 (9.6)

Active Device vs Sham Device: Cohen's d: -0.04
Active Device vs Sham Device: Cohen's d: 0.24
Active Device vs Sham Device: Cohen's d: 0.80

Population analysed: The same 10 (total) participants are represented in Arm/Group (repeated-measures)

Primary outcome: 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).. Mean (Standard Deviation). Unit: Sum score, on a scale of 0-28

Measure	Active Device n = 9	Sham Device n = 9
Value	7.3 (4.4)	6.8 (5.0)

Active Device vs Sham Device: Cohen's d: 0.11

Population analysed: In this repeated-measures design, one participant had missing data for an Insomnia Severity Index (ISI) measure. Therefore, the analyzed sample for ISI Outcome is n=9 (5 Active Device Phase 1, then Sham; + 4 Sham Device Phase 1, then Active), rather than n=10.

Adverse events

Time frame: Systematic event monitoring occurred at a minimum of each scheduled polysomnography (night sleep monitoring) visit (6 total nights): twice during Baseline (1 week, at beginning and end), twice during Phase 1 (3 weeks, at end of 2nd week and end of 3rd week), and twice during Phase 2 (3 weeks, at end of 2nd week and at end of 3rd week). Non-systematic event monitoring also occurred throughout the 8 weeks of study data collection per participant, and across participants 9/28/2024 - 5/10/2024.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Device	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Sham Device	0 of 10 (0%)	3 of 10 (30%)	0 of 10

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Activated Sleep Pad system (Frequen-ZZZ) and Deactivated Sleep Pad system (Frequen-ZZZ) in people with Insomnia and Sleep, run by Kunasan Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.