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NCT03646214 · ClinicalTrials.gov registry record · NA
Improving Sleep Quality During Pregnancy Using an Oral Appliance
A NA study of Snoring and Sleep Fragmentation, sponsored by Texas A&M University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03646214: Recruiting NA study of Snoring and Sleep Fragmentation, sponsored by Texas A&M University.
NCT03646214 is a NA study of Snoring and Sleep Fragmentation that is actively recruiting participants, run by Texas A&M University. The registered enrollment target is 20 participants, below the 51-participant average among 7 other Snoring trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03646214, a NA study of Snoring and Sleep Fragmentation, is actively recruiting participants, sponsored by Texas A&M University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Snoring is a variant of obstructive sleep apnea (OSA) and OSA during pregnancy is associated with higher risks for cesarean delivery, gestational hypertension, preeclampsia and preterm delivery. It may also impact fetal outcomes negatively. The purpose of this study is to determine whether sleep quality can be improved in pregnant women who snore by means of an oral appliance that opens the airway. Sleep quality is evaluated objectively using an un-intrusive home sleep test system.
Primary Outcome
Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.
Conditions Studied
Interventions
- DEVICE Midline traction oral appliance
Study Locations (1)
Texas
- Texas A&M University College of Dentistry - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2026-07-30 |
| Phase | NA |
What NCT03646214 shows while recruiting
NCT03646214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 51-participant average among 7 other Snoring trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Snoring appearing as the primary indexed condition, and to 1 intervention - of which Midline traction oral appliance is the first listed.
NCT03646214 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03646214 about?
NCT03646214 is a clinical study titled "Improving Sleep Quality During Pregnancy Using an Oral Appliance". Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Snoring is a variant of obstructive sleep apnea (OSA) and OSA during pregnancy is associated ...
What is the current status of trial NCT03646214?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2018-02-01. Estimated completion is 2026-07-30.
What conditions does trial NCT03646214 study?
This clinical trial studies the following conditions: Snoring, Sleep Fragmentation.
What interventions are being tested in trial NCT03646214?
The interventions under investigation include: Midline traction oral appliance (DEVICE).
Who is sponsoring clinical trial NCT03646214?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03646214 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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