Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
Texas A&M University
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.
Description
As many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. The purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral appliance (OA) that opens the airway. This is an interventional study to objectively evaluate OA therapy on breathing during sleep as well as its effect on sleep quality. Pregnant women from all trimesters will be recruited. Each subject is expected to participate in the study for at least five (5) consecutive weeks. Home sleep recordings will be collected at three time p…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
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 uvulopalatopha…
Interventions
- DeviceMidline traction oral appliance
Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
Location
- Texas A&M University College of DentistryDallas, Texas