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Improving Sleep Quality During Pregnancy Using an Oral Appliance

NCT03646214 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-07

No results posted yet for this study

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.

Conditions

  • Snoring
  • Sleep Fragmentation

Interventions

DEVICE

Midline traction oral appliance

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

Sponsors & Collaborators

Principal Investigators

  • Emet D Schneiderman, PhD · Texas A&M University College of Dentistry

  • Preetam J Schramm, PhD · Texas A&M University College of Dentistry

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2026-04-30
Completion
2026-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03646214 on ClinicalTrials.gov