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 ↗
Who can join
Age 18 Years – 45 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- Pregnant > 32 weeks
- Uncontrolled serious health issues
- Cardiovascular or cardiac rhythm disorders
- Pharmacological dependency
- Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol
- Ongoing temporomandibular joint disorders
- Loose teeth or periodontal disease
- History of uvulopalatopharyngoplasty (UPPP)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openTexas A&M University College of Dentistry
Dallas, Texas, United States
- Zohre German, MS · Contact214-828-8291german@tamu.edu
- Jason Hui, DDS · Sub-investigator
- Duane Wilson, DDS · Sub-investigator
- Ann McCann, PhD · Sub-investigator
- Pollyana Moura, DDS · Sub-investigator
Recruiting
Study team
Sponsor
Texas A&M University
Study ID IRB2018-0048
Principal investigator
Emet D Schneiderman, PhD
Texas A&M University College of Dentistry
Principal investigator
Preetam J Schramm, PhD
Texas A&M University College of Dentistry
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.