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Improving Sleep Quality During Pregnancy Using an Oral Appliance

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

Who can join

Ages 18 to 45 · Women · Healthy volunteers welcome

Inclusion Criteria:

* Pregnant adults who snore
* At least 8 teeth per arch
* Mallampati score from I to II
* Palatine tonsils grade 0,1 or 2
* Capable of giving verbal and written informed consent
* Able to apply the sleep recorder and the oral appliance.

Exclusion Criteria:

* Pregnant \> 32 weeks
* Uncontrolled serious health issues
* Cardiovascular or cardiac rhythm disorders
* Pharmacological dependency
* Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol
* Ongoing temporomandibular joint disorders
* Loose teeth or periodontal disease
* History of uvulopalatopharyngoplasty (UPPP)

About the study

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.

What is being tested

• Midline traction oral appliance (device)

Sponsor: Texas A&M University · Participants: 20 · Started: Feb 1, 2018

Contact the study team

• Zohre German, MS · Phone: 214-828-8291

Official record on ClinicalTrials.gov — NCT03646214

Locations in the U.S.

Conditions

• Snoring

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.