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Improving Sleep Quality During Pregnancy Using an Oral Appliance

Texas A&M University · NCT03646214

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
February 1, 2018
Record last updated
October 7, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Midline traction oral appliance

Conditions: Snoring; Sleep Fragmentation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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)

Recruiting US locations

  • Texas A&M University College of Dentistry

    Dallas, TX 75246

    Site contact: Zohre German, MS · 214-828-8291 · german@tamu.edu

Study contacts (from the official record)

  • Zohre German, MS · 214-828-8291 · german@tamhsc.edu
All sleep studies in Texas →
Improving Sleep Quality During Pregnancy Using an Oral Appliance (NCT03646214) | Bored Studies