Oral Appliance for Snoring during Pregnancy

(PREGNCCT Trial)

Overseen By Zohre German, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Texas A&M University

Must not be taking: Hypnotics, Sleep aids, Nicotine, Alcohol

Disqualifiers: Cardiovascular disorders, Pharmacological dependency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an oral appliance can enhance sleep quality in pregnant women who snore. Snoring can cause serious health issues, such as high blood pressure and complications during delivery. Participants will either use the midline traction oral appliance, which keeps the airway open, or have their sleep monitored without intervention. Pregnant women who snore and have at least eight teeth per arch may qualify as candidates. The trial lasts four weeks, and participants wear the oral appliance at night. As an unphased trial, this study offers participants the chance to contribute to important research that could improve sleep health for pregnant women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using sleep aids, nicotine, or alcohol.

What prior data suggests that this oral appliance is safe for pregnant women?

Research has shown that oral devices, such as the midline traction oral appliance, are generally well-tolerated for treating snoring and sleep apnea in non-pregnant individuals. These devices help keep the airway open, improving sleep quality. However, limited safety information exists regarding their use during pregnancy.

One study suggested that these devices can improve sleep and reduce snoring. Another source, however, advises caution and recommends discontinuing their use during pregnancy and breastfeeding due to insufficient safety information for these periods. While these devices are usually safe, their effects during pregnancy remain unclear.

In summary, although oral devices assist many with sleep issues, more research is needed to confirm their safety for pregnant women. Prospective trial participants should discuss these considerations with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for snoring during pregnancy, like nasal strips, position change, or CPAP machines, aim to improve airflow or change sleeping posture. But the midline traction oral appliance works differently. It gently repositions the jaw to keep the airway open during sleep, potentially reducing snoring and improving sleep quality. Researchers are excited because this device offers a non-invasive alternative that doesn’t rely on external airflow or uncomfortable masks, making it more comfortable for pregnant users. Plus, it’s designed for nightly use, which might lead to consistent improvements in sleep-related breathing issues.

What evidence suggests that this oral appliance is effective for improving sleep quality in pregnant women who snore?

Research has shown that a midline traction oral appliance, which participants in this trial may use, can improve sleep by keeping the airway open and potentially reducing snoring. Studies have found these oral devices effective in treating obstructive sleep apnea (OSA), a condition linked to snoring. This is important because OSA during pregnancy can cause problems like high blood pressure and early delivery. By reducing snoring and improving sleep, the oral appliance might help lower these risks. Early findings suggest that using this device can lead to better sleep, which is vital for the health of both mother and baby. ^{1 2 3 5 6}

Who Is on the Research Team?

Emet D Schneiderman, PhD

Principal Investigator

Texas A&M University College of Dentistry

Preetam J Schramm, PhD

Principal Investigator

Texas A&M University College of Dentistry

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Adult women who are pregnant and snore.

You have at least 8 teeth in each row of your mouth.

Your Mallampati score is between I and II.

Exclusion Criteria

You have had a surgery called uvulopalatopharyngoplasty (UPPP) in the past.

You are currently taking sleeping pills or other drugs to help you sleep, or you use nicotine or drink alcohol.

You currently have jaw joint problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Home sleep recordings are collected for two consecutive nights prior to oral appliance use

1 week

Home sleep test

Treatment

Participants use the oral appliance nightly for 4 weeks with sleep recordings at specified intervals

4 weeks

Home sleep test at 3 time points

Follow-up

Participants are monitored for sleep quality and other outcomes after the treatment phase

4 weeks

Home sleep test at 8-week intervals

Open-label extension (optional)

Participants may continue to use the oral appliance and have their sleep recorded at 8-week intervals through the remainder of their pregnancies

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Midline traction oral appliance

Trial Overview 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.

How Is the Trial Designed?

Group I: Midline traction oral appliance Experimental Treatment 1 Intervention

Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.

Group II: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

Citations

1. trialx.com trialx.com/clinical-trials/listings/264345/improving-sleep-quality-during-pregnancy-using-an-oral-appliance/?&radius=50

Improving Sleep Quality During Pregnancy Using an Oral ... The purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/34/NCT03219034/Prot_SAP_001.pdf

Midline traction versus bilateral thrust oral appliances This study will compare the effectiveness of the two leading designs of oral appliances (OAs) for treating moderate to severe obstructive sleep apnea (OSA) in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4818216/

Sleep disordered breathing in pregnancy - PubMed Central Longitudinal studies have shown that habitual snoring (three or more nights per week) increases from 7–11% [13–15] in the first trimester to 16–25% in the third ...

4. openrespiratorymedicinejournal.com openrespiratorymedicinejournal.com/VOLUME/19/ELOCATOR/e18743064411633/PDF/

Obstructive Sleep Apnea in Pregnancy and its Impact on ... Another anticipated outcome of OSA in pregnancy is an increased rate of preterm births. Possible reasons include low pro- gesterone levels ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01030003

Snoring in Pregnancy and Adverse Maternal and Fetal ... The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35829947/

Adherence and efficacy of mandibular advancement splint ... Mandibular advancement splints (MAS) have been shown to improve sleep quality, daytime sleepiness and snoring in non-pregnant women.