ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Disordered Breathing and Gestational Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00757718
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : September 9, 2009
Sponsor:
Information provided by:
University of Saskatchewan

September 22, 2008
September 23, 2008
September 9, 2009
December 2008
July 2009   (Final data collection date for primary outcome measure)
Effectiveness of the two treatment arms at treating sleep disordered breathing. [ Time Frame: single night ]
Same as current
Complete list of historical versions of study NCT00757718 on ClinicalTrials.gov Archive Site
  • Effectiveness of the treatment arms at improving metabolic perturbations of GHTN. [ Time Frame: single night ]
  • Acceptability of therapy [ Time Frame: single night ]
Same as current
Not Provided
Not Provided
 
Sleep Disordered Breathing and Gestational Hypertension
Sleep Disordered Breathing and Gestational Hypertension
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Sleep Disordered Breathing
  • Obstructive Sleep Apnea
  • Gestational Hypertension
  • Preeclampsia
  • 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.
    Other Names:
    • Respironics M Series Autoset CPAP
    • Somnoguard AP oral apliance
    • Breathe Right Nasal Srip
  • 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.
    Other Names:
    • Somnoguard AP
    • Breathe Right nasal strip
  • 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.
    Intervention: Device: CPAP
  • 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.
    Intervention: Device: Oral Appliance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Same as current
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with singleton pregnancies who have the diagnosis of gestational hypertension.

Exclusion Criteria:

  • Inability to comply with study parameters
  • Delivery expected within 48 hours
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00757718
Bio: 08-21
No
Not Provided
Not Provided
John K. Reid, Assistant Professor of Medicine, University of Saskatchewan
University of Saskatchewan
Not Provided
Principal Investigator: John K Reid, MD University of Saskatchewan
University of Saskatchewan
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP