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Midline Traction Oral Appliance

Oral Appliance for Snoring during Pregnancy (PREGNCCT Trial)

N/A
Recruiting
Led By Emet D Schneiderman, PhD
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at each of 3 time points over 5 weeks
Awards & highlights

Summary

This trialaims to improve sleep quality for pregnant women who snore, to reduce risks for cesarean delivery, gestational hypertension, preeclampsia & preterm delivery. Sleep quality is measured using a home sleep test.

Who is the study for?
This trial is for pregnant adults who snore, have a good number of teeth and a certain throat structure (Mallampati score I to II), and no serious health issues. They must be less than 32 weeks pregnant, not dependent on drugs or alcohol, and able to use the sleep test system and oral appliance.
What is being tested?
The study tests if an oral appliance that adjusts the position of the jaw can improve sleep quality in snoring pregnant women. Participants' sleep will be monitored at home using a special device to see if there's any improvement.
What are the potential side effects?
Potential side effects may include discomfort from wearing the oral appliance, jaw pain, changes in bite alignment, or increased salivation. However, these are generally mild.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at each of 3 time points over 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at each of 3 time points over 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ratio of stable to unstable sleep from CPC
Secondary study objectives
Fatigue Severity Scale (FSS)
Hamilton Depression Rating Scale (HDRS)
Insomnia Sleep Questionnaire (ISQ)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Midline traction oral applianceExperimental Treatment1 Intervention
Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.
Group II: ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
146 Previous Clinical Trials
24,916 Total Patients Enrolled
Emet D Schneiderman, PhDPrincipal InvestigatorTexas A&M University College of Dentistry
Preetam J Schramm, PhDPrincipal InvestigatorTexas A&M University College of Dentistry

Media Library

Midline traction oral appliance (Midline Traction Oral Appliance) Clinical Trial Eligibility Overview. Trial Name: NCT03646214 — N/A
Sleep Fragmentation Research Study Groups: Midline traction oral appliance, Control
Sleep Fragmentation Clinical Trial 2023: Midline traction oral appliance Highlights & Side Effects. Trial Name: NCT03646214 — N/A
Midline traction oral appliance (Midline Traction Oral Appliance) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03646214 — N/A
~3 spots leftby Sep 2025
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