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SnoringSleepPregnancyDental and oral healthDevice

What this study is

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.

What's being tested

  • Midline traction oral appliance

    Intervention · DEVICE

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

Study details

Official title
Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
Sponsor
Texas A&M University
Conditions
Snoring · Sleep Fragmentation
Enrolling
20 people
Starts
2018-02-01
Est. completion
2026-07-30
Design
Single-blind, non-randomized, parallel groups
Record
View on ClinicalTrials.gov ↗