Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
Not Applicable
- Conditions
- Sleep Disturbance
- Interventions
- Other: Natural Frequency Patch
- Registration Number
- NCT03205631
- Lead Sponsor
- IC-IT Sciences Inc.
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active Natural Frequency Patch Natural Frequency Patch - Sham Natural Frequency Patch Natural Frequency Patch -
- Primary Outcome Measures
Name Time Method Sleep Quality three nights Assess sleep via home EEG recording
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
California Center for Sleep Disorders
🇺🇸Alameda, California, United States