Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT03646214

Improving Sleep Quality During Pregnancy Using an Oral Appliance

Led by Texas A&M University · Updated on 2025-10-07

20

Participants Needed

1

Research Sites

443 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Improving Sleep Quality During Pregnancy Using an Oral Appliance

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant adults who snore
  • Have at least 8 teeth per arch
  • Mallampati score of I or II
  • Palatine tonsils grade 0, 1, or 2
  • Able to give verbal and written informed consent
  • Able to use the sleep recorder and oral appliance
Not Eligible

You will not qualify if you...

  • Pregnant beyond 32 weeks
  • Have uncontrolled serious health issues
  • Have cardiovascular or cardiac rhythm disorders
  • Are pharmacologically dependent
  • Use hypnotic agents, sleep aids, nicotine, or alcohol
  • Have ongoing temporomandibular joint disorders
  • Have loose teeth or periodontal disease
  • History of uvulopalatopharyngoplasty (UPPP)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Texas A&M University College of Dentistry

Dallas, Texas, United States, 75246

Actively Recruiting

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Research Team

Z

Zohre German, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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