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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03205631
• Other study ID #: NFT-001
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2017
• Last updated: June 29, 2017
• Start date: June 26, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: IC-IT Sciences Inc.
• Contact: robyn woidtke
• Phone: 5107280828
• Email: robyn.woidtke[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	California Center for Sleep Disorders	Alameda	California

Sponsors (1)

Lead Sponsor	Collaborator
IC-IT Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	Assess sleep via home EEG recording	three nights