Research Exploring Sleep Education & Technology

Sleep Health Clinical Trial

— RESET  

Official title:

Research Exploring Sleep Education & Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489460
• Other study ID #: 17-01591
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1060
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Health

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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