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NCT04246424 · ClinicalTrials.gov registry record · NA
Randomized Experiment of Sleep Technology
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT04246424: Completed NA study, sponsored by University of Utah.
NCT04246424 is a NA study that has completed, run by University of Utah. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04246424, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
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.
Primary Outcome
Assess changes in sleep quality:Using the Philips Respironics Actiwatch (scoring completed using Philips Actiware 6), sleep duration and sleep quality will be assessed. Measures include bed/wake time, total time in bed, total sleep time, onset latency, sleep efficiency, number of awakenings and minutes awake during the night, or Wake After Sleep Onset (WASO). White, red, green and blue light will be measured using the device but only white light will be used in the assessment.
Interventions
- BEHAVIORAL Fitbit
- BEHAVIORAL Coaching
- BEHAVIORAL Fibit + Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-01-16 |
| Est. Completion | 2020-04-27 |
| Phase | NA |
What the finished NCT04246424 record still lists
NCT04246424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Fitbit is the first listed.
NCT04246424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04246424 about?
NCT04246424 is a clinical study titled "Randomized Experiment of Sleep Technology". 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 \[2\]. Thes...
What is the current status of trial NCT04246424?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2019-01-16. Estimated completion is 2020-04-27.
What interventions are being tested in trial NCT04246424?
The interventions under investigation include: Fitbit (BEHAVIORAL), Coaching (BEHAVIORAL), Fibit + Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT04246424?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04246424's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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