Sleep Disordered Breathing and Gestational Hypertension
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|ClinicalTrials.gov Identifier: NCT00757718|
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : September 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disordered Breathing Obstructive Sleep Apnea Gestational Hypertension Preeclampsia||Device: CPAP Device: Oral Appliance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Sleep Disordered Breathing and Gestational Hypertension|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Active Comparator: CPAP treatment
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.
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.
Experimental: Oral appliance
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.
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.
- Effectiveness of the two treatment arms at treating sleep disordered breathing. [ Time Frame: single night ]
- Effectiveness of the treatment arms at improving metabolic perturbations of GHTN. [ Time Frame: single night ]
- Acceptability of therapy [ Time Frame: single night ]
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): NCT00757718
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||John K Reid, MD||University of Saskatchewan|