Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2017
CompletedFirst Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJuly 2, 2017
June 1, 2017
6 months
June 29, 2017
June 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep Quality
Assess sleep via home EEG recording
three nights
Study Arms (2)
Sham Natural Frequency Patch
SHAM COMPARATORActive Natural Frequency Patch
ACTIVE COMPARATORInterventions
Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
California Center for Sleep Disorders
Alameda, California, 94501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 2, 2017
Study Start
June 26, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
July 2, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share