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Frequen-ZZZ SleepPad Investigational Device POC

NCT05908344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-16

Study results available
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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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER

  • Kunasan Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2024-05-10
Completion
2024-05-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908344 on ClinicalTrials.gov