Improving Sleep Quality During Pregnancy Using an Oral Appliance (PREGNCCT)
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|ClinicalTrials.gov Identifier: NCT03646214|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Snoring Sleep Fragmentation||Device: Midline traction oral appliance||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Controlled clinical trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes assessor reading the sleep studies will have the treatment arm masked.|
|Official Title:||Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Experimental: Midline traction oral appliance
Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.
Device: Midline traction oral appliance
Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
No Intervention: Control
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.
- Sleep quality [ Time Frame: 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.
- Snoring [ Time Frame: At each of 3 time points over 5 weeks ]Number of snores and snore index (#snores/hour of sleep)
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646214
|Contact: Zohre German, MSemail@example.com|
|United States, Texas|
|Texas A&M University College of Dentistry||Recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Zohre German, MS 214-828-8291 firstname.lastname@example.org|
|Sub-Investigator: Jason Hui, DDS|
|Sub-Investigator: Duane Wilson, DDS|
|Sub-Investigator: Ann McCann, PhD|
|Sub-Investigator: Pollyana Moura, DDS|
|Principal Investigator:||Emet D Schneiderman, PhD||Texas A&M University College of Dentistry|
|Principal Investigator:||Preetam J Schramm, PhD||Texas A&M University College of Dentistry|