Sleep Disordered Breathing and Gestational Hypertension
Primary Purpose
Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CPAP
Oral Appliance
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disordered Breathing focused on measuring Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia
Eligibility 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
Sites / Locations
- Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CPAP treatment
Oral appliance
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Effectiveness of the two treatment arms at treating sleep disordered breathing.
Secondary Outcome Measures
Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.
Acceptability of therapy
Full Information
NCT ID
NCT00757718
First Posted
September 22, 2008
Last Updated
September 4, 2009
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT00757718
Brief Title
Sleep Disordered Breathing and Gestational Hypertension
Official Title
Sleep Disordered Breathing and Gestational Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Saskatchewan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia
Keywords
Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oral appliance
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Respironics M Series Autoset CPAP, Somnoguard AP oral apliance, Breathe Right Nasal Srip
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oral Appliance
Other Intervention Name(s)
Somnoguard AP, Breathe Right nasal strip
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of the two treatment arms at treating sleep disordered breathing.
Time Frame
single night
Secondary Outcome Measure Information:
Title
Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.
Time Frame
single night
Title
Acceptability of therapy
Time Frame
single night
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John K Reid, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
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Sleep Disordered Breathing and Gestational Hypertension
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