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Sponsored by: |
University of Saskatchewan |
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Information provided by: | University of Saskatchewan |
ClinicalTrials.gov Identifier: | NCT00757718 |
Sleep disordered breathing (SDB) is a common problem in the adult population. By conservative estimates, 4% of the adult female population has SDB. SDB is a recognized cause of hypertension and treating SDB can improve blood pressure control in people with hypertension. More recently, research efforts have looked at SDB as a possible cause of pregnancy induced hypertension (PIH), a condition which complicates 10% of pregnancies. Traditionally, the best way to assess SDB required patients to spend a night sleeping in the Sleep Laboratory. This is inconvenient and for pregnant women often impossible to arrange, considering the short time frame that exists between time of PIH diagnosis and eventual delivery. Researchers at the University of Saskatchewan are now looking at whether an adequate sleep assessment can be performed at the bedside - either in a patient's home or on the hospital ward. The researchers will also look at different treatment options for sleep apnea, to see if these can improve blood pressure control in this patient population, and delay the need for early delivery. The information from this study may result in a detailed sleep assessment becoming part of the complete assessment of women with PIH. There is an association between sleep disordered breathing (SDB) and gestational hypertension (GHTN). Treatment for the SDB may represent an effective addition to the management of the cardiovascular and metabolic perturbations of GHTN We plan to assess women whether treating SDB with one of two methods will improve the management of GHTN. We will also assess if one method is more effective than the other.
Condition | Intervention |
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Sleep Disordered Breathing Obstructive Sleep Apnea Gestational Hypertension Preeclampsia |
Device: CPAP Device: Oral Appliance |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Sleep Disordered Breathing and Gestational Hypertension |
Estimated Enrollment: | 26 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CPAP treatment: Active Comparator
Subjects will have repeat polysomnography on the second night, while wearing a continuous positive airway pressure (CPAP) device. Morning bloodwork will be drawn for inflammatory mediators.
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Device: CPAP
One half of the subjects will be randomly assigned to wear continuous a positive airway pressure device on the second night of the study. Portable polysomnography will be repeated for this night and morning bloodwork for inflammatory markers will be repeated.
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Oral appliance: Experimental
Subjects will have repeat polysomnography on the second night, while wearing an oral appliance, as well as a Breathe-Right nasal strip. Morning bloodwork will be drawn for inflammatory mediators.
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Device: Oral Appliance
Half of the subjects will be assigned to wear an oral appliance and nasal strip on the second night of the study. Repeat portable polysomnography will be performed and morning bloodwork will again be drawn for inflammatory markers.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John K Reid, MD | 306 966-8503 | j.reid@usask.ca |
Contact: Robert Skomro, MD | 306 966-8694 | r.skomro@usask.ca |
Canada, Saskatchewan | |
Royal University Hospital | Recruiting |
Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
Contact: John K Reid, MD (306) 966-8503 j.reid@usask.ca | |
Contact: Rob Skomro, MD (306) 966-8694 r.skomro@usask.ca | |
Principal Investigator: John K Reid, MD | |
Sub-Investigator: Rob Skomro, MD |
Principal Investigator: | John K Reid, MD | University of Saskatchewan |
Responsible Party: | University of Saskatchewan ( John K. Reid, Assistant Professor of Medicine ) |
Study ID Numbers: | Bio: 08-21 |
Study First Received: | September 22, 2008 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00757718 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Sleep Disordered Breathing Obstructive Sleep Apnea Gestational Hypertension Preeclampsia |
Sleep Apnea Syndromes Pregnancy Complications Eclampsia Apnea Sleep Apnea, Obstructive Respiration Disorders Vascular Diseases Dyssomnias |
Pre-Eclampsia Sleep Disorders Preeclampsia Sleep Disorders, Intrinsic Hypertension, Pregnancy-Induced Respiratory Tract Diseases Hypertension |
Sleep Apnea Syndromes Pregnancy Complications Apnea Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders Vascular Diseases Sleep Disorders |
Pre-Eclampsia Dyssomnias Sleep Disorders, Intrinsic Hypertension, Pregnancy-Induced Respiratory Tract Diseases Cardiovascular Diseases Hypertension |