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NCT03783663 · ClinicalTrials.gov registry record · NA
Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device
A NA study, sponsored by University of Massachusetts, Amherst.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT03783663: Completed NA study, sponsored by University of Massachusetts, Amherst.
NCT03783663 is a NA study that has completed, run by University of Massachusetts, Amherst. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03783663, a NA study, has completed, sponsored by University of Massachusetts, Amherst.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
Pregnancy-associated sleep disorders are a common acute experience in pregnancy experienced by up to 82% of women. Sleep disorders are associated with increased risk for pre-eclampsia, gestational diabetes, longer labor, cesarean birth, and postpartum depression, and are higher among pregnant women of lower socioeconomic status. Traditional clinical management of sleep disorders in pregnancy includes education and counseling on sleep hygiene and sleep positioning, dietary modifications, relaxation, iron supplementation, weight management, and physical activity, yet education-based behavioral interventions show minimal effectiveness for improving sleep among pregnant women. These methods typically do not incorporate objective self-monitoring, which is an important behavior change technique. In pregnancy, objective self-monitoring on a day-to-day basis is particularly important as sleep disorders may worsen as pregnancy progresses. Computer-based personalized health monitoring (PHM) devices may serve as an effective tool with which pregnant women can self-manage sleep through incorporation of regular feedback. This strategy may be beneficial not only for women with pregnancy-associated sleep disorders but also for pregnant women with less severe sleep disruptions that experience daytime sleepiness, fatigue, and decreased quality of life. PHM devices have been used to promote weight loss, diet, and physical activity changes but no studies have specifically targeted sleep among pregnant women. The purpose of this pilot study is to establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management with pregnant women using a PHM device, in order to refine the intervention for a larger, randomized trial.
Primary Outcome
To assess feasibility of the study, we will calculate the number and percentage of participants in both groups that remain in the study for the entire study period. The study will be considered as feasible if at least 80% of participants remain in the study for its entirety.
Interventions
- BEHAVIORAL Misfit Shine 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2018-08-27 |
| Phase | NA |
What the finished NCT03783663 record still lists
NCT03783663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Misfit Shine 2 is the first listed.
NCT03783663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03783663 about?
NCT03783663 is a clinical study titled "Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device". Pregnancy-associated sleep disorders are a common acute experience in pregnancy experienced by up to 82% of women. Sleep disorders are associated with increased risk for pre-eclampsia, gestational diabetes, longer labor, cesarean birth, and postpartum depression, and are higher among pregnant women ...
What is the current status of trial NCT03783663?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2017-09-01. Estimated completion is 2018-08-27.
What interventions are being tested in trial NCT03783663?
The interventions under investigation include: Misfit Shine 2 (BEHAVIORAL).
Who is sponsoring clinical trial NCT03783663?
This trial is sponsored by University of Massachusetts, Amherst, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03783663's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 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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