Improving Sleep Quality During Pregnancy Using an Oral Appliance
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 8/26/2018 |
| Start Date: | February 1, 2018 |
| End Date: | August 31, 2019 |
| Contact: | Zohre German, MS |
| Email: | german@tamhsc.edu |
| Phone: | 214-828-8291 |
Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical 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.
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.
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.
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.
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)
We found this trial at
1
site
3302 Gaston Avenue
Dallas, Texas 75246
Dallas, Texas 75246
Phone: 214-828-8291
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