Improving Sleep Quality During Pregnancy Using an Oral Appliance

Recruiting now · Not applicable

Conditions studied: Snoring, Sleep Fragmentation

In brief

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.

Key facts

Study ID

NCT03646214

Run by

Texas A&M University

People needed

20

Starts

2018-02-01

Expected to finish

2026-07-30

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Texas A&M University College of Dentistry — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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