RecruitingNot ApplicableNCT03646214

Improving Sleep Quality During Pregnancy Using an Oral Appliance

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


Sponsor

Texas A&M University

Enrollment

20 participants

Start Date

Feb 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Midline traction oral appliance for people with sleep fragmentation and snoring. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMidline 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

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NCT03646214


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