Improving Sleep Quality During Pregnancy Using an Oral Appliance

Part of paid clinical trials in Dallas, Texas.

Sponsor
Texas A&M University
Study ID
NCT03646214
Status
Recruiting
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Conditions

  • Sleep Fragmentation
  • Snoring

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Midline traction oral appliance — DEVICE
    Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.

Study Details

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.

Key Dates

Start date
Feb 1, 2018
Status verified
Oct 2025
Primary completion
Apr 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Midline traction oral appliance
    Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.
  • No Intervention: 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.

Primary Outcome Measure

Ratio of stable to unstable sleep from CPC [ Time Frame: Two nights of sleep recordings at each of 3 time point over 5 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas A&M University College of DentistryDallasTexas75246
Zohre German, MS
[email protected]
214-828-8291
Jason Hui, DDS (SUB_INVESTIGATOR)
Duane Wilson, DDS (SUB_INVESTIGATOR)
Ann McCann, PhD (SUB_INVESTIGATOR)
Pollyana Moura, DDS (SUB_INVESTIGATOR)

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By research site
Texas A&M University College of Dentistry· Dallas, TX

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