Improving Sleep Quality During Pregnancy Using an Oral Appliance

This study is looking at whether a special mouthguard, called a midline traction oral appliance, can help pregnant women who snore get better sleep. Many pregnant women experience snoring and poor sleep, which can be linked to health issues for both mother and baby. The oral appliance works by gently moving your lower jaw forward to open up your airway. Researchers will measure your sleep quality using home sleep recordings over five weeks to see if the appliance makes a difference. To join, you should be a pregnant woman between 18 and 45 years old who snores, and meet other health criteria. The study aims to enroll up to 20 participants.

Study design
This is an interventional study with up to 20 participants, where everyone receives the oral appliance.
What's involved
You would participate for at least five consecutive weeks, completing home sleep recordings at three different times and filling out surveys. You would also learn to apply the sleep recorder and oral appliance.
Compensation
Not stated in the trial record.
Follow-up
After the initial 4-week period, you can continue to use the oral appliance and have your sleep recorded at 8-week intervals for the rest of your pregnancy.

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NCT03646214

Improving Sleep Quality During Pregnancy Using an Oral Appliance

Recruiting
NAAges 18–45InterventionalTreatment
Texas A&M University
~20 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:Midline traction oral appliance

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ratio of stable to unstable sleep from CPC
Measured over Two nights of sleep recordings at each of 3 time point over 5 weeks.
Snoring
Sleep Fragmentation
1 sites across 1 states
Texas1
  • Emet D Schneiderman, PhD · PRINCIPAL_INVESTIGATOR · Texas A&M University College of Dentistry
  • Preetam J Schramm, PhD · PRINCIPAL_INVESTIGATOR · Texas A&M University College of Dentistry

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Eligibility criteria

Inclusion

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

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)
  • Ratio of stable to unstable sleep from CPCTwo nights of sleep recordings at each of 3 time point over 5 weeks.

    Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.