Research Exploring Sleep Education & Technology

NCT03489460 — Not applicable, Completed, 1060 participants, NYU Langone Health

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Registry	NCT03489460, acronym RESET
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	1060 (Actual)
Sponsor	NYU Langone Health (Other)
Conditions	Sleep Health
Interventions	Specialized sleep-related message interventions, GAD (Behavioral)
Dates	start 2019-02-01, primary completion 2019-08-01, completion 2019-08-01, first posted 2018-04-05, last updated 2020-01-30
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Receive sleep health messages + GAD	Active comparator	Behavioral: Specialized sleep-related message interventions; Behavioral: GAD	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.
Sleep message No GAD	Active comparator	Behavioral: Specialized sleep-related message interventions	For two weeks participants agree to receive sleep health messages and wear the GAD

Specialized sleep-related message interventions (Behavioral): Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.
GAD (Behavioral): 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.

+Outcome measures

Primary outcomes

Sleep time measured by wearable mobile sleep tracking technology [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 [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 [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) [15 Days]: 8 scale measure divided into 4 separate scales: Scale 1: "Pre-Contemplation" Scale 2: "Contemplation" Scale 3 "Action" Scale 4 "Maintenance"

+Eligibility

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Non English speakers.

+Locations (1)

Facility	City	Country	Status
New York University School of Medicine	New York, New York	United States

+Investigators

Girardin Jean-Louis, MD, Principal investigator, NYU Langone Health

My Notes

Public

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