Use of an oral appliance to reduce snoring and improve sleep during pregnancy
Official title: Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
Run by Texas A&M University · NCT03646214 · Data updated 2026-11-12
This will test whether a removable midline traction oral appliance can reduce snoring and improve sleep quality for pregnant women who snore.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Texas A&M University Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | February 1, 2018 |
| Main results expected | April 30, 2026 |
| Study ends | July 30, 2026 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT03646214 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant adults who currently snore, have at least eight teeth per arch, Mallampati I–II, palatine tonsils grade 0–2, can consent and use the home sleep recorder and appliance, and are ≤32 weeks pregnant are the intended participants.
✕Probably not a fit
People more than 32 weeks pregnant, those with uncontrolled serious illness, cardiovascular or rhythm disorders, TMJ problems, loose teeth/periodontal disease, prior UPPP, or who refuse to wear an oral appliance are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant adults who snore will be fitted with a midline traction oral appliance and monitored with unintrusive home sleep recordings at baseline, during initial use, and after four weeks of nightly use. Each participant is expected to complete at least five consecutive weeks of participation, with the option to continue device use and periodic home recordings through the remainder of pregnancy. Objective breathing and sleep measures are collected for two consecutive nights at each time point, and participants complete brief surveys about sleep. Participants keep their oral appliance after the study.
Why it matters
Potential benefit: If successful, the oral appliance could reduce snoring and improve sleep quality for pregnant people and potentially lower risks linked to pregnancy sleep-disordered breathing.
How similar studies have gone: Oral appliances have been shown to reduce snoring and mild-to-moderate obstructive sleep apnea in nonpregnant adults, but their use specifically in pregnant populations has been less studied.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Texas A&M University College of Dentistry
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Emet D Schneiderman, PhD — Texas A&M University College of Dentistry
- Study coordinator: Zohre German, MS
- Email: german@tamhsc.edu
- Phone: 214-828-8291
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.