NCT03489460

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,060

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

March 26, 2018

Last Update Submit

January 29, 2020

Conditions

Sleep Health

Keywords

sleep health

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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"

    15 Days

Study Arms (2)

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.

Behavioral: Specialized sleep-related message interventionsBehavioral: GAD

Sleep message No GAD

ACTIVE COMPARATOR

For two weeks participants agree to receive sleep health messages and wear the GAD

Behavioral: Specialized sleep-related message interventions

Interventions

Specialized sleep-related message interventionsBEHAVIORAL

Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.

Receive sleep health messages + GADSleep message No GAD
GADBEHAVIORAL

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.

Receive sleep health messages + GAD

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A current user of the OURA ring activity and sleep tracker device.
  • Health conscious.

You may not qualify if:

  • Non English speakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

  • Girardin Jean-Louis, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 5, 2018

Study Start

February 1, 2019

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Immediately following publication. No end date
Access Criteria
Requests should be directed to Rebecca.robbins@nyulangone.org. To gain access, data requestors will need to sign a data access agreement

Locations

US(1)