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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

PREGNCCT Trial 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.Check my eligibility

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.See study design

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.

PREGNCCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at each of 3 time points over 5 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ratio of stable to unstable sleep from CPC

Secondary outcome measures

Fatigue Severity Scale (FSS)

Hamilton Depression Rating Scale (HDRS)

Insomnia Sleep Questionnaire (ISQ)

+2 more

PREGNCCT 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor

140 Previous Clinical Trials

24,086 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor seeking participants aged 18 and over?

"According to the trial's inclusion criteria, only individuals between 18 and 45 years of age are eligible for enrolment. Notably, there exist 7 studies that cater specifically to those under 18, while 22 trials focus on elderly patients over 65."

Answered by AI

Are there any openings for volunteers in this clinical experiment?

"Affirmative. According to the information on clinicaltrials.gov, this trial is in search of participants, which it first posted about on February 1st 2018 and edited lastly on October 28th 2022. 20 people are being enrolled between a single medical centre."

Answered by AI

Is it feasible for me to become involved in this medical trial?

"Applicants to this trial must have a history of snoring and be part of the 18-45 age range. Only 20 participants are going to be accepted in total."

Answered by AI

How many participants are part of this trial experiment?

"Affirmative. As per the clinicaltrials.gov record, this research endeavour is currently engaging volunteers. It was initiated on February 1st 2018 and most recently revised on October 28th 2022; 20 individuals are required at a single centre for participation in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Sleep Quality During Pregnancy Using an Oral Appliance

Emet D. Schneiderman, PhD 2018. "Improving Sleep Quality During Pregnancy Using an Oral Appliance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03646214.

All > Pregnancy