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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03205631
Enrollment
50
Registered
2017-07-02
Start date
2017-06-26
Completion date
2017-12-31
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disturbance

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

OTHERNatural 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

Sponsors

IC-IT Sciences Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Sleep Qualitythree nightsAssess sleep via home EEG recording

Countries

United States

Contacts

Primary Contactrobyn woidtke
robyn.woidtke@gmail.com5107280828
Backup ContactNeil Branda, PhD
nbranda@sfu.ca(778)7828061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026