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

Primary Purpose

Sleep Disturbance

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Natural Frequency Patch
Sponsored by
IC-IT Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • California Center for Sleep DisordersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham Natural Frequency Patch

Active Natural Frequency Patch

Arm Description

Outcomes

Primary Outcome Measures

Sleep Quality
Assess sleep via home EEG recording

Secondary Outcome Measures

Full Information

First Posted
June 29, 2017
Last Updated
June 29, 2017
Sponsor
IC-IT Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03205631
Brief Title
Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
Official Title
Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IC-IT Sciences Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Natural Frequency Patch
Arm Type
Sham Comparator
Arm Title
Active Natural Frequency Patch
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Natural Frequency Patch
Intervention Description
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 Information:
Title
Sleep Quality
Description
Assess sleep via home EEG recording
Time Frame
three nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
robyn woidtke
Phone
5107280828
Email
robyn.woidtke@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Branda, PhD
Phone
(778)7828061
Email
nbranda@sfu.ca
Facility Information:
Facility Name
California Center for Sleep Disorders
City
Alameda
State/Province
California
ZIP/Postal Code
94501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachelle Desille
Phone
510-263-3331
Email
research@sleepdx.com
First Name & Middle Initial & Last Name & Degree
Jerrold Kram, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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