Recruiting

Oral Appliance

Sponsor:

Texas A&M University

Code:

NCT03646214

Conditions

Snoring

Sleep Fragmentation

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Midline traction oral appliance

Study Details

Brief 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.

Conditions

Snoring

Sleep Fragmentation

Study ID

NCT03646214

Start date

Feb 1, 2018

Status verified date

Oct, 2025

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Midline traction oral appliance

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

Primary outcome measure

  • Ratio of stable to unstable sleep from CPC [ Time Frame: Two nights of sleep recordings at each of 3 time point over 5 weeks. ]

Central Contacts and Locations

Central contacts

Zohre German, MS

214-828-8291german@tamhsc.edu

Locations

Texas A&M University College of Dentistry

Recruiting

Dallas, Texas, United States, 75246

Contacts

Zohre German, MS

214-828-8291german@tamu.edu

More Information

Sponsor

Texas A&M University

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas A&M University on 2025-10-07.