Research Exploring Sleep Education & Technology (RESET)

January 29, 2020 updated by: NYU Langone Health
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1060

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Receive sleep health messages + 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.
Behavioral: Specialized sleep-related message interventions
Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.
Behavioral: GAD
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.
Active Comparator: Sleep message No GAD
For two weeks participants agree to receive sleep health messages and wear the GAD
Behavioral: Specialized sleep-related message interventions
Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 Days
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
15 Days
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
1 Day
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"
15 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Girardin Jean-Louis, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-01591

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date

IPD Sharing Access Criteria

Requests should be directed to Rebecca.robbins@nyulangone.org. To gain access, data requestors will need to sign a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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