Improving Sleep Quality During Pregnancy Using an Oral Appliance

NCT03646214 | Recruiting FDA Device

• 1 other identifier: IRB2018-0048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Ratio of stable to unstable sleep from CPC

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

  Two nights of sleep recordings at each of 3 time point over 5 weeks.

Secondary Outcomes (5)

• Number of snores per hour of sleep

  At each of 3 time points over 5 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  At baseline and after 5 weeks

• Insomnia Sleep Questionnaire (ISQ)

  At baseline and after 5 weeks

• Hamilton Depression Rating Scale (HDRS)

  At baseline and after 5 weeks

• Fatigue Severity Scale (FSS)

  At baseline and after 5 weeks

Study Arms (2)

Midline traction oral appliance

EXPERIMENTAL

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

Device: Midline traction oral appliance

Control

NO INTERVENTION

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

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

Also known as: MyTAP oral appliance, Mandibular advancement device

Midline traction oral appliance

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Snoring; Sleep Deprivation

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Emet D Schneiderman, PhD

  Texas A&M University College of Dentistry

  PRINCIPAL INVESTIGATOR

• Preetam J Schramm, PhD

  Texas A&M University College of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zohre German, MS

CONTACT

214-828-8291; german@tamhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor reading the sleep studies will have the treatment arm masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Biomedical Sciences

Model Details: Controlled clinical trial

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: August 24, 2018
• Study Start: February 1, 2018
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)