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Sleep Disordered Breathing and Gestational Hypertension
This study is currently recruiting participants.
Verified by University of Saskatchewan, September 2008
First Received: September 22, 2008   Last Updated: March 2, 2009   History of Changes
Sponsored by: University of Saskatchewan
Information provided by: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00757718
  Purpose

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
Sleep Disordered Breathing
Obstructive Sleep Apnea
Gestational Hypertension
Preeclampsia
Device: CPAP
Device: Oral Appliance

MedlinePlus related topics: High Blood Pressure High Blood Pressure in Pregnancy Sleep Apnea
U.S. FDA Resources
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

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Effectiveness of the two treatment arms at treating sleep disordered breathing. [ Time Frame: single night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness of the treatment arms at improving metabolic perturbations of GHTN. [ Time Frame: single night ] [ Designated as safety issue: No ]
  • Acceptability of therapy [ Time Frame: single night ] [ Designated as safety issue: No ]

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
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757718

Contacts
Contact: John K Reid, MD 306 966-8503 j.reid@usask.ca
Contact: Robert Skomro, MD 306 966-8694 r.skomro@usask.ca

Locations
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            
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: John K Reid, MD University of Saskatchewan
  More Information

No publications provided

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

Keywords provided by University of Saskatchewan:
Sleep Disordered Breathing
Obstructive Sleep Apnea
Gestational Hypertension
Preeclampsia

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009