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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Sleep Disturbance

In brief

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

Key facts

Study ID

NCT03205631

Run by

IC-IT Sciences Inc.

People needed

50

Starts

2017-06-26

Expected to finish

2017-12-31

Last updated by the study team

2017-07-02

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Center for Sleep Disorders — Alameda, California, United States (enrolling)

Full record on ClinicalTrials.gov

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