Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment

NCT ID: NCT03205631

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2017-12-31

Brief Summary

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Prospective, randomized crossover study to compare the NFT sleep patches to sham device to assess sleep via home sleep testing device in the home environment

Detailed Description

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Conditions

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Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sham Natural Frequency Patch

Group Type SHAM_COMPARATOR

Natural Frequency Patch

Intervention Type OTHER

Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights

Active Natural Frequency Patch

Group Type ACTIVE_COMPARATOR

Natural Frequency Patch

Intervention Type OTHER

Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights

Interventions

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Natural Frequency Patch

Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* capacity to provide informed consent
* BMI \<30
* between 30 and 65 years old
* in overall good health as determined by history and physical assessment subjects pre-screened to ensure they are drug free
* work a typical day job/work week.
* not traveled \> 3 time zones in the last month
* typical bedtime between 9-12 PM
* estimated on average 6 hours per night
* negative urine drug screen
* have self-reported unrefreshing sleep for the past month
* agree to limit alcohol use to no more than two drinks a night during the testing period and four hours prior to bedtime
* agree to limit caffeine consumption to four hours prior to bedtime
* ≤ 2 on the depression scale
* ≤ 3 on the anxiety scale

Exclusion Criteria

* pregnant or nursing a child
* self-induced short sleep habits (\<6 hours per night)
* unstable medical conditions as determined by the clinician
* current sleep disorder (sleep apnea AHI/REI\<5, restless legs, periodic limb movements, narcolepsy)
* self-reported sleep latency of \>30 minutes or early (3-4 AM) awakenings on a regular basis
* contact dermatitis to adhesives
* excluded Medications: over the counter sleep aids, prescribed sleep aids, central nervous system stimulants, antidepressants, sedating antihistamines, over the counter decongestants and opioids
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IC-IT Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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California Center for Sleep Disorders

Alameda, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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robyn woidtke

Role: CONTACT

5107280828

Neil Branda, PhD

Role: CONTACT

(778)7828061

Facility Contacts

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Rachelle Desille

Role: primary

510-263-3331

Other Identifiers

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NFT-001

Identifier Type: -

Identifier Source: org_study_id

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