Randomized Experiment of Sleep Technology

NCT04246424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-02-04

No results posted yet for this study

Summary

Short sleep duration is highly prevalent and linked to negative mental and physical health consequences, including increased cardiovascular disease risk \[1\]. According to data from the National Health Interview Survey, 70.1 million U.S. adults (29.2%) sleep \<6 hours per 24 hour period \[2\]. These statistics are a stark contrast to recommendations made by a recent consensus panel of sleep experts that concluded "at least 7 hours" is the amount of sleep needed for health and performance among adults \[3\]. Therefore, a high number of U.S. adults could benefit from extending sleep duration. Several small experiments have demonstrated the benefits of short-term sleep extension \[4-8\]. However, these studies are limited by extending sleep as a temporary experimental manipulation rather than a longer-term behavioral intervention. To deliver sleep extension interventions, wearable sleep trackers may be useful, particularly given the rapid uptake among consumers (+500% in 3 years) \[9\]. We have developed a novel technology-assisted behavioral sleep extension intervention that employs four elements -- a wearable sleep tracker, didactic content, an interactive smartphone feature and brief telephone counseling. User testing supports feasibility of extending sleep, but little is known about the effects of differing types of technology interventions on sleep. Therefore, the goal of this study is to examine the differences between technology sleep extension interventions and sleep duration.

Conditions

  • Sleep

Interventions

BEHAVIORAL

Fibit + Coaching

This intervention is a combination of the coaching and fitbit interventions

BEHAVIORAL

Coaching

Coaching Participants who are assigned coaching group will receive telephone coaching. Coaches follow a guide developed by Kelly Glazer Baron, Jennifer Duffecy, Kathryn Reid, and Lauren Caccamo. The first session is an approximately 30 minute engagement session, with the purpose of "getting to know" the participant to increase likelihood for participation. The end goal is to have participants express Desire, Ability, Reason, Need, Can (DARN-C) to make changes in sleep). The remainder calls (week 2-6) are follow-up calls lasting about 5 minutes. The goal of these calls is to keep participants motivated and address any issues with the Fitbit hard or software. Participants will also receive weekly email lessons to their personal email address for 1-6 weeks.

BEHAVIORAL

Fitbit

Fitbit Participants in the fitbit group will receive a Fitbit Charge 3 black, and asked to wear it for 1-6 weeks. Participants will monitor their sleep through the sleep section in the Fitbit app on the smartphone. Participants will be provided login information so that researchers can access this data and asked to keep Bluetooth on. After week 6, participants can choose to continue to wear the device for the duration of the study (12 weeks). Though wear at weeks 7-12 is not required, researchers will still use any data that was collected from the fitbit during that time. At the completion of their participation, researchers retain the login information and the device is switched to a personal login of the participants choice.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2020-04-27
Completion
2020-04-27

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246424 on ClinicalTrials.gov