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Improving Sleep Quality During Pregnancy Using an Oral Appliance

Study acronym: PREGNCCT
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated October 7, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Mar 11, 2023 to Apr 30, 2026
    • Study completion date: Dec 31, 2023 to Jul 30, 2026
    v4
  2. Primary completion date: May 31, 2021 to Mar 11, 2023
    • Study completion date: Dec 31, 2021 to Dec 31, 2023
    • Site contact updated
    v3
  3. Primary completion date: Jan 31, 2019 to May 31, 2021
    • Primary endpoint revised
    • Study completion date: Aug 31, 2019 to Dec 31, 2021
    • Secondary endpoints revised (5)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03646214
Lead Sponsor Texas A&M University
Conditions
(from sponsor)		 Snoring, Sleep Fragmentation
Related terms Sleep Deprivation, Snoring
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov