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CompletedNCT03489460RESETUpdated Jan 30, 2020

Research Exploring Sleep Education & Technology

An interventional study of Specialized sleep-related message interventions and GAD in Sleep Health, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,060
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sleep Health

Keywords

  • sleep health
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Non English speakers.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,060 participants (actual)

Study arms

  • 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 · Behavioral: GAD

  • 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

Interventions

  • BehavioralSpecialized 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.

  • BehavioralGAD

    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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 15 Days

  2. 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

    Time frame: 15 Days

  3. 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

    Time frame: 1 Day

  4. 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"

    Time frame: 15 Days

06

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
07

References and documents

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03489460
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Apr 5, 2018
Start date
Feb 1, 2019
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Jan 30, 2020

Study contacts

Girardin Jean-Louis, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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