Improving Sleep Quality During Pregnancy Using an Oral Appliance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTexas A&M University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant adults who snore
At least 8 teeth per arch
Mallampati score from I to II
Palatine tonsils grade 0,1 or 2
Disqualifiers
Pregnant > 32 weeks
Uncontrolled serious health issues
Cardiovascular or cardiac rhythm disorders
Pharmacological dependency
Trial design
Design model
Parallel
Treatments tested in this trial
Midline traction oral appliance
DeviceDevice positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Midline traction oral applianceExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Ratio of stable to unstable sleep from CPC
Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.
Time frame
Two nights of sleep recordings at each of 3 time point over 5 weeks.Secondary outcomes
1
Number of snores per hour of sleep
Number of snores and snore index (#snores/hour of sleep)
Time frame
At each of 3 time points over 5 weeks2
Pittsburgh Sleep Quality Index (PSQI)
Self reported measures concerning sleep over a 1-month period; overall score ranging from 0 to 21; Scores \>7 suggests poor sleep quality.
Time frame
At baseline and after 5 weeks3
Insomnia Sleep Questionnaire (ISQ)
A screening tool used to guide in the clinical evaluation of insomnia; Scores 3, 4 or 5 to two or more items suggests significant daytime impairment and further evaluation of insomnia.
Time frame
At baseline and after 5 weeks4
Hamilton Depression Rating Scale (HDRS)
Used to provide an indication of depression, and as a guide to evaluate recovery; Higher scores = depression severity. Score \>20 suggests depression severity.
Time frame
At baseline and after 5 weeksSponsors and contacts
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Source ClinicalTrials.gov