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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
United States
Texas
Texas A&M University College of Dentistry
RECRUITING
Dallas
Contact Information
Primary
Zohre German, MS
german@tamhsc.edu
214-828-8291
Time Frame
Start Date: 2018-02-01
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 20
Treatments
Experimental: Midline traction oral appliance
Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.
No_intervention: Control
Subjects who do do not wish to wear the oral appliance will have their sleep monitored in parallel to the experimental subjects for 4 weeks.
Sponsors
Leads: Texas A&M University

This content was sourced from clinicaltrials.gov

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