Sleep Fragmentation, Snoring
Conditions
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.
Interventions
DEVICEMidline traction oral appliance
Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
Sponsors
Texas A&M University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor reading the sleep studies will have the treatment arm masked.
Intervention model description
Controlled clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of stable to unstable sleep from CPC | Two nights of sleep recordings at each of 3 time point over 5 weeks. | Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of snores per hour of sleep | At each of 3 time points over 5 weeks | Number of snores and snore index (#snores/hour of sleep) |
| Pittsburgh Sleep Quality Index (PSQI) | At baseline and after 5 weeks | Self reported measures concerning sleep over a 1-month period; overall score ranging from 0 to 21; Scores \>7 suggests poor sleep quality. |
| Insomnia Sleep Questionnaire (ISQ) | At baseline and after 5 weeks | 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. |
| Hamilton Depression Rating Scale (HDRS) | At baseline and after 5 weeks | Used to provide an indication of depression, and as a guide to evaluate recovery; Higher scores = depression severity. Score \>20 suggests depression severity. |
| Fatigue Severity Scale (FSS) | At baseline and after 5 weeks | 9-item scale which measures the severity of fatigue and its effect on a person's activities; and lifestyle. Higher scores = greater fatigue severity. Minimum score = 9; Maximum score = 63. |
Countries
United States
Contacts
Primary ContactZohre German, MS
Outcome results
None listed