Recruiting

Natural Frequencies

Sponsor:

IC-IT Sciences Inc.

Code:

NCT03205631

Conditions

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Accepted

Interventions

Natural Frequency Patch

Study Details

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

Conditions

Sleep Disturbance

Study ID

NCT03205631

Start date

Jun 26, 2017

Status verified date

Jun, 2017

Completion date

Dec 31, 2017

Anticipated

Primary completion date

Dec 31, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham Natural Frequency Patch

active comparator: Active Natural Frequency Patch

Interventions

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

Primary outcome measure

  • Sleep Quality [ Time Frame: three nights ]

Central Contacts and Locations

Central contacts

robyn woidtke

5107280828robyn.woidtke@gmail.com

Neil Branda, PhD

(778)7828061nbranda@sfu.ca

Locations

California Center for Sleep Disorders

Recruiting

Alameda, California, United States, 94501

Contacts

Rachelle Desille

510-263-3331research@sleepdx.com

Principal Investigator:

Jerrold Kram, MD

More Information

Sponsor

IC-IT Sciences Inc.

Last update posted

Jul 2, 2017

Last verified

Jun, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IC-IT Sciences Inc. on 2017-07-02.