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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 is a NA study that has completed, run by University of Massachusetts, Amherst. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03783663
The ClinicalTrials.gov registry entry for NCT03783663 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Amherst, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Misfit Shine 2 is the first listed.
NCT03783663 reports 0 study locations.
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.
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