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RECRUITING
NCT03646214
NA

Improving Sleep Quality During Pregnancy Using an Oral Appliance

Sponsor: Texas A&M University

View on ClinicalTrials.gov

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.

Official title: Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2018-02-01

Completion Date

2026-07-30

Last Updated

2025-10-07

Healthy Volunteers

Yes

Interventions

DEVICE

Midline traction oral appliance

Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.

Locations (1)

Texas A&M University College of Dentistry

Dallas, Texas, United States