NCT03646214 Improving Sleep Quality During Pregnancy Using an Oral Appliance
| NCT ID | NCT03646214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Texas A&M University |
| Condition | Snoring |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2018-02-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2018-02-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Emet D Schneiderman, PhD
PRINCIPAL INVESTIGATOR
Texas A&M University College of Dentistry
Frequently Asked Questions
Who can join the NCT03646214 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Snoring. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03646214 currently recruiting?
Yes, NCT03646214 is actively recruiting participants. Contact the research team at german@tamhsc.edu for enrollment information.
Where is the NCT03646214 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT03646214 clinical trial?
NCT03646214 is sponsored by Texas A&M University. The principal investigator is Emet D Schneiderman, PhD at Texas A&M University College of Dentistry. The trial plans to enroll 20 participants.