Snoring Clinical Trial
— PREGNCCTOfficial title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2023 |
Est. primary completion date | March 11, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Texas A&M University College of Dentistry | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas A&M University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratio of stable to unstable sleep from CPC | Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis. | Two nights of sleep recordings at each of 3 time point over 5 weeks. | |
Secondary | Number of snores per hour of sleep | Number of snores and snore index (#snores/hour of sleep) | At each of 3 time points over 5 weeks | |
Secondary | 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. | At baseline and after 5 weeks | |
Secondary | 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. | At baseline and after 5 weeks | |
Secondary | 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. | At baseline and after 5 weeks | |
Secondary | Fatigue Severity Scale (FSS) | 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. | At baseline and after 5 weeks |
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