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NCT Number: NCT03646214

Improving Sleep Quality During Pregnancy Using an Oral Appliance

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Midline traction oral appliance

Device

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

Other names: MyTAP oral appliance, Mandibular advancement device

Primary outcomes

  1. Ratio of stable to unstable sleep from CPC

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

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

Secondary outcomes

  1. Number of snores per hour of sleep

    Time frame: At each of 3 time points over 5 weeks

    Number of snores and snore index (#snores/hour of sleep)

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At baseline and after 5 weeks

    Self reported measures concerning sleep over a 1-month period; overall score ranging from 0 to 21; Scores >7 suggests poor sleep quality.

  3. Insomnia Sleep Questionnaire (ISQ)

    Time frame: At baseline and after 5 weeks

    A screening tool used to guide in the clinical evaluation of insomnia; Scores 3, 4 or 5 to two or more items suggests significant daytime impairment and further evaluation of insomnia.

  4. Hamilton Depression Rating Scale (HDRS)

    Time frame: At baseline and after 5 weeks

    Used to provide an indication of depression, and as a guide to evaluate recovery; Higher scores = depression severity. Score >20 suggests depression severity.

  5. Fatigue Severity Scale (FSS)

    Time frame: At baseline and after 5 weeks

    9-item scale which measures the severity of fatigue and its effect on a person's activities; and lifestyle. Higher scores = greater fatigue severity. Minimum score = 9; Maximum score = 63.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Official study title

Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial

Acronym: PREGNCCT

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2018
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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