Improving Sleep Quality During Pregnancy Using an Oral Appliance (PREGNCCT)

Texas A&M University

Status: Enrolling

Conditions: Snoring; Sleep Fragmentation

Treatments: Device: Midline traction oral appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT03646214

IRB2018-0048

Details and patient eligibility

About

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.

Full description

As many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. 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 appliance (OA) that opens the airway. This is an interventional study to objectively evaluate OA therapy on breathing during sleep as well as its effect on sleep quality. Pregnant women from all trimesters will be recruited. Each subject is expected to participate in the study for at least five (5) consecutive weeks. Home sleep recordings will be collected at three time points: T0 - Baseline prior to OA use for two consecutive nights; T1- first two consecutive nights wearing the OA; T2 - for two consecutive nights after 4 weeks of appliance use. In addition to the sleep studies performed at each of these time points, subjects will also complete several brief surveys. All participants will be given the opportunity to use their OAs after the 4 week period, and have their sleep recorded at 8 week intervals through the remainder of their pregnancies. Participants will get to keep and use their OAs after the study.

Pregnant women who snore (or otherwise have poor sleep), may qualify to participate in this study. Those who do not want to wear an oral appliance, but are interested in learning about sleep quality while pregnant, may also qualify to participate as a control subject.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant adults who snore
• At least 8 teeth per arch
• Mallampati score from I to II
• Palatine tonsils grade 0,1 or 2
• Capable of giving verbal and written informed consent
• Able to apply the sleep recorder and the oral appliance.

Exclusion criteria

• Pregnant > 32 weeks
• Uncontrolled serious health issues
• Cardiovascular or cardiac rhythm disorders
• Pharmacological dependency
• Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol
• Ongoing temporomandibular joint disorders
• Loose teeth or periodontal disease
• History of uvulopalatopharyngoplasty (UPPP)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Midline traction oral appliance

Experimental group

Description:

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

Treatment:

Device: Midline traction oral appliance

Control

No Intervention group

Description:

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.