Improving Sleep Quality During Pregnancy Using an Oral Appliance
Eligible age
18–45 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this 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.
Sponsor: Texas A&M University
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's recruiting
Dallas
Source: ClinicalTrials.gov · NCT03646214 · last updated 2025-10-07