Sleep DisturbanceNCT03205631
Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
A study testing Natural Frequency Patch in people with Sleep Disturbance, run by IC-IT Sciences Inc. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Natural Frequency Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California Center for Sleep Disorders
Alameda, California, 94501
Rachelle Desille, 510-263-3331, research@sleepdx.com
Jerrold Kram, MD
About this study
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
- Being tested
- Natural Frequency Patch
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Frequency PatchOther
Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights
| Study group | Role | What they receive |
|---|---|---|
| Sham Natural Frequency Patch | Sham comparator | Not described Receives: Other: Natural Frequency Patch |
| Active Natural Frequency Patch | Active comparator | Not described Receives: Other: Natural Frequency Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Assess sleep via home EEG recording
Measured: three nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start26 Jun 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IC-IT Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205631
- Sponsor's protocol ID
- NFT-001
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment
- ClinicalTrials.gov ID
- NCT03205631
- Acronym / sponsor ID
- NFT-001
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IC-IT Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Natural Frequency Patch | Sham comparator | Other: Natural Frequency Patch |
| Active Natural Frequency Patch | Active comparator | Other: Natural Frequency Patch |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Frequency PatchParticipants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights | Other | Active Natural Frequency Patch, Sham Natural Frequency Patch |
Primary outcome
Sleep Quality
Time frame: three nights
Assess sleep via home EEG recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Frequency Patch in people with Sleep Disturbance, run by IC-IT Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact robyn woidtke (5107280828, robyn.woidtke@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: three nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.