Clinical Trial

Oral Device Improving Sleep Quality During Pregnancy

Study Description

Improving Sleep Quality During Pregnancy Using an Oral Appliance

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Device - Midline traction oral appliance

Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03646214

ParticipAid ID

eER80a