Actively Recruiting
Improving Sleep Quality During Pregnancy Using an Oral Appliance
Led by Texas A&M University · Updated on 2025-10-07
20
Participants Needed
1
Research Sites
443 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Sleep Quality During Pregnancy Using an Oral Appliance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant adults who snore
- Have at least 8 teeth per arch
- Mallampati score of I or II
- Palatine tonsils grade 0, 1, or 2
- Able to give verbal and written informed consent
- Able to use the sleep recorder and oral appliance
You will not qualify if you...
- Pregnant beyond 32 weeks
- Have uncontrolled serious health issues
- Have cardiovascular or cardiac rhythm disorders
- Are pharmacologically dependent
- Use hypnotic agents, sleep aids, nicotine, or alcohol
- Have ongoing temporomandibular joint disorders
- Have loose teeth or periodontal disease
- History of uvulopalatopharyngoplasty (UPPP)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas A&M University College of Dentistry
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
Z
Zohre German, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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