Clinical Trial

Improving Sleep Quality During Pregnancy Using an Oral Appliance

Study acronym: PREGNCCT
Recruiting
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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.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2018-08-22; most recent amendment 2025-10-01.
Trial Details
NCT Number NCT03646214
Lead Sponsor Texas A&M University
Conditions Snoring, Sleep Fragmentation
Enrollment 20 participants
Start Date 2018-02-01
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-07