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

IC-IT Sciences

Status

Unknown

Conditions

Sleep Disturbance

Treatments

Other: Natural Frequency Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT03205631

NFT-001

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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