Sleep Disturbance
Conditions
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
Interventions
Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | three nights | Assess sleep via home EEG recording |
Countries
United States