Improving Sleep Quality During Pregnancy Using an Oral Appliance

NCT ID: NCT03646214

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2026-07-30

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.

Detailed Description

As many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. The purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral appliance (OA) that opens the airway. This is an interventional study to objectively evaluate OA therapy on breathing during sleep as well as its effect on sleep quality. Pregnant women from all trimesters will be recruited. Each subject is expected to participate in the study for at least five (5) consecutive weeks. Home sleep recordings will be collected at three time points: T0 - Baseline prior to OA use for two consecutive nights; T1- first two consecutive nights wearing the OA; T2 - for two consecutive nights after 4 weeks of appliance use. In addition to the sleep studies performed at each of these time points, subjects will also complete several brief surveys. All participants will be given the opportunity to use their OAs after the 4 week period, and have their sleep recorded at 8 week intervals through the remainder of their pregnancies. Participants will get to keep and use their OAs after the study.

Pregnant women who snore (or otherwise have poor sleep), may qualify to participate in this study. Those who do not want to wear an oral appliance, but are interested in learning about sleep quality while pregnant, may also qualify to participate as a control subject.

Conditions

Snoring; Sleep Fragmentation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Midline traction oral appliance

Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.

Group Type: EXPERIMENTAL

Midline traction oral appliance

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Midline traction oral appliance

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

Intervention Type: DEVICE

Other Intervention Names

MyTAP oral appliance; Mandibular advancement device

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Emet D. Schneiderman, PhD

Professor, Biomedical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emet D Schneiderman, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University College of Dentistry

Preetam J Schramm, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University College of Dentistry

Locations

Texas A&M University College of Dentistry

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zohre German, MS

Role: CONTACT

german@tamhsc.edu

214-828-8291

Facility Contacts

Zohre German, MS

Role: primary

german@tamu.edu

214-828-8291

Other Identifiers

IRB2018-0048

Identifier Type: -

Identifier Source: org_study_id