CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Activated Sleep Pad system (Frequen-ZZZ) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05908344
NCT05908344N/ACompleted
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Use of the Frequen-ZZZ Sleep Pad to Increase Restorative Sleep: A Proof-of-Concept Study

Kunasan Inc.·interventional·Posted Jun 18, 2023·Updated Dec 16, 2024

In Brief

A clinical study evaluating Activated Sleep Pad system (Frequen-ZZZ) and Deactivated Sleep Pad system (Frequen-ZZZ) for Insomnia and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Sleep, Sleep Disturbance
CountriesUnited States
CollaboratorsPenn State University

Timeline

N/ACompletedFinished
202420252026
First PostedJun 18, 2023
Enrollment StartJul 21, 2023
Primary CompletionMay 10, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.0 years ago

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.

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.