Clinical trial NCT03646214: Improving Sleep Quality During Pregnancy Using an Oral Appliance
Official title: Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Snoring
Sleep Fragmentation
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Ratio of stable to unstable sleep from CPC
timeFrame: Two nights of sleep recordings at each of 3 time point over 5 weeks.
Secondary outcomes:
measure: Number of snores per hour of sleep
timeFrame: At each of 3 time points over 5 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline and after 5 weeks
measure: Insomnia Sleep Questionnaire (ISQ)
timeFrame: At baseline and after 5 weeks
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: At baseline and after 5 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: At baseline and after 5 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M University College of Dentistry
state: Texas
Study officials:
affiliation: Texas A&M University College of Dentistry
name: Emet D Schneiderman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas A&M University College of Dentistry
name: Preetam J Schramm, PhD
role: PRINCIPAL_INVESTIGATOR
References: