Improving Sleep Quality During Pregnancy Using an Oral Appliance

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTexas A&M University

About this trial

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 criteria

Qualifiers

Pregnant adults who snore

At least 8 teeth per arch

Mallampati score from I to II

Palatine tonsils grade 0,1 or 2

Disqualifiers

Pregnant > 32 weeks

Uncontrolled serious health issues

Cardiovascular or cardiac rhythm disorders

Pharmacological dependency

Trial design

Treatments tested in this trial

  • Midline traction oral appliance

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators