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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 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.

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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.

Interventions

  • DEVICE Midline traction oral appliance

Study Locations (1)

Texas

  • Texas A&M University College of Dentistry - Dallas

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-02-01
Est. Completion 2026-07-30
Phase NA

Sponsor

Texas A&M University

95 total trials

What the Registry Record Tells You About NCT03646214

The ClinicalTrials.gov registry entry for NCT03646214 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 51-participant average among 7 other Snoring trials with a reported enrollment target (61% lower). The listed sponsor is Texas A&M University, which has 95 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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