SleepNCT04508595
The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance
An observational study of Sleep, run by Tanzen Medical Inc at 1 site in United States.
Trial summary
This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Sleep
- What is being tested?
- RestEaze
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2020to 6 Aug 2021
- Phase
- Observational
- 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 5 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: Outpatients presenting to sleep medicine clinic for evaluation.
Who may be able to join
- Ages between 5 -75
- General good health and ambulatory
- Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG
- Reports no significant problems sleeping in a new bed and bedroom away from home
- (If applicable) Parent or guardian available to spend the night with the child during the sleep study
Who cannot join
- Amputation that would preclude use of wrist actigraph or the RestEaze device
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Comprehensive Sleep Center
Milpitas, California, 95035
Sanjay Agarwal, MD, 408-942-0300, drsanjay@yahoo.com
About this study
This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.
- Conditions
- Sleep
- Being tested
- RestEaze
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestEazeDiagnostic test
Wearable band to detect leg movements of sleep
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm
Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start8 Aug 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion6 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanzen Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508595
- Sponsor's protocol ID
- TM-RE1-OBS-0001
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- 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 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RestEaze Ambulatory Sleep Monitor for Detection of Leg Movements During Sleep in Adults and Children With a Sleep Disturbance
- ClinicalTrials.gov ID
- NCT04508595
- Acronym / sponsor ID
- TM-RE1-OBS-0001
- Conditions
- Sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tanzen Medical IncIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 6 Aug 2021 (estimated)
- First posted
- 11 Aug 2020 (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.
This observational study will test and evaluate the RestEaze ambulatory sleep monitor for the detection and classification of leg movements during sleep (LMS) and other sleep measures.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients presenting to sleep medicine clinic for evaluation.
Key inclusion criteria (5 listed)
- Ages between 5 -75
- General good health and ambulatory
- Sleep complaint or other diagnosis that affects sleep (e.g. ADHD) with likely concomitant abnormal LMS requiring either HST or PSG
- Reports no significant problems sleeping in a new bed and bedroom away from home
- (If applicable) Parent or guardian available to spend the night with the child during the sleep study
Key exclusion criteria (1 listed)
- Amputation that would preclude use of wrist actigraph or the RestEaze device
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 |
|---|---|---|
| RestEazeWearable band to detect leg movements of sleep | Diagnostic test | – |
Primary outcome
Algorithm
Time frame: 1 year
Development of analysis tools to validate RestEaze as a biomarker of leg movements of sleep
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- 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?
An observational study of Sleep, run by Tanzen Medical 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 5 inclusion and 1 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 11 Aug 2020. 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. 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 Justin Brooks, MD,PhD (7575811363, jrybrooks@tanzenmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm (time frame: 1 year). 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 11 Aug 2020.