Sleep HealthRESETNCT03489460
Research Exploring Sleep Education & Technology
A study testing Specialized sleep-related message interventions and GAD in people with Sleep Health, run by NYU Langone Health at 1 site in United States.
Trial summary
A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking technologies, and optimal sleep health educational strategies among users of mobile wearable technologies that track sleep. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Health
- What is being tested?
- Specialized sleep-related message interventions and GAD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 1 Aug 2019
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A current user of the OURA ring activity and sleep tracker device.
- For Aim 3 MOST message testing, the inclusion criteria include the following:
- Health conscious.
Who cannot join
- Non English speakers.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking technologies, and optimal sleep health educational strategies among users of mobile wearable technologies that track sleep.
- Conditions
- Sleep Health
- Being tested
- Specialized sleep-related message interventions, GAD
- Keywords
- sleep health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized sleep-related message interventionsBehavioural
Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.
GADBehavioural
Survey responses will be merged with objective GAD data (sleep time, time in deep sleep, physical activity) which will assist in developing message design formats for message testing.
| Study group | Role | What they receive |
|---|---|---|
| Receive sleep health messages + GAD | Active comparator | Procedures will be delivered to users of the GAD, individuals who have opted in via their smartphone application, to receive messages about various areas of health. Receives: Behavioral: Specialized sleep-related message interventions; Behavioral: GAD |
| Sleep message No GAD | Active comparator | For two weeks participants agree to receive sleep health messages and wear the GAD Receives: Behavioral: Specialized sleep-related message interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep time measured by wearable mobile sleep tracking technology
Mobile sleep tracking device will be worn by patient for 15 days and will measure sleep patterns in patients
Measured: 15 Days
Time in deep sleep measured by wearable mobile sleep tracking technology
Mobile sleep tracking device will be worn by patient for 15 days and will measure sleep patterns in patients
Measured: 15 Days
Dysfunctional Beliefs about Sleep (DBAS) scale
24-item DBAS scale with five subscales corresponding to: (1) consequences of insomnia (2) control and predictability of sleep (3) sleep requirement expectations (5) sleep-promoting practices
Measured: 1 Day
Measure of motivation to change using the Change Assessment Scale (CAS)
8 scale measure divided into 4 separate scales: Scale 1: "Pre-Contemplation" Scale 2: "Contemplation" Scale 3 "Action" Scale 4 "Maintenance"
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Feb 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HealthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,060 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Girardin Jean-Louis, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489460
- Sponsor's protocol ID
- 17-01591
- Acronym
- RESET
- Status last verified
- Jan 2020
- First submitted
- 26 Mar 2018
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Exploring Sleep Education & Technology
- ClinicalTrials.gov ID
- NCT03489460
- Acronym / sponsor ID
- RESET / 17-01591
- Conditions
- Sleep Health
- Keywords
- sleep health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,060 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 5 Apr 2018 (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.
A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking technologies, and optimal sleep health educational strategies among users of mobile wearable technologies that track sleep.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive sleep health messages + GAD | Active comparator | Behavioral: Specialized sleep-related message interventions, Behavioral: GADProcedures will be delivered to users of the GAD, individuals who have opted in via their smartphone application, to receive messages about various areas of health. |
| Sleep message No GAD | Active comparator | Behavioral: Specialized sleep-related message interventionsFor two weeks participants agree to receive sleep health messages and wear the GAD |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A current user of the OURA ring activity and sleep tracker device.
- Health conscious.
Key exclusion criteria (1 listed)
- Non English speakers.
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 |
|---|---|---|
| Specialized sleep-related message interventionsOver the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application. | Behavioural | Receive sleep health messages + GAD, Sleep message No GAD |
| GADSurvey responses will be merged with objective GAD data (sleep time, time in deep sleep, physical activity) which will assist in developing message design formats for message testing. | Behavioural | Receive sleep health messages + GAD |
Primary outcome
Sleep time measured by wearable mobile sleep tracking technology
Time frame: 15 Days
Mobile sleep tracking device will be worn by patient for 15 days and will measure sleep patterns in patients
Time in deep sleep measured by wearable mobile sleep tracking technology
Time frame: 15 Days
Mobile sleep tracking device will be worn by patient for 15 days and will measure sleep patterns in patients
Dysfunctional Beliefs about Sleep (DBAS) scale
Time frame: 1 Day
24-item DBAS scale with five subscales corresponding to: (1) consequences of insomnia (2) control and predictability of sleep (3) sleep requirement expectations (5) sleep-promoting practices
Measure of motivation to change using the Change Assessment Scale (CAS)
Time frame: 15 Days
8 scale measure divided into 4 separate scales: Scale 1: "Pre-Contemplation" Scale 2: "Contemplation" Scale 3 "Action" Scale 4 "Maintenance"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Girardin Jean-Louis, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized sleep-related message interventions and GAD in people with Sleep Health, run by NYU Langone Health 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 3 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: finished, as of the sponsor's last update on 30 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep time measured by wearable mobile sleep tracking technology (time frame: 15 Days). The study lists 4 primary outcomes in all. 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 30 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.