Sleep Disordered Breathing and Gestational Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Sleep Disordered Breathing and Gestational Hypertension

Conditions
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Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia

Intervention / Treatment
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* Device: CPAP
* Device: Oral Appliance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP treatment<br>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<br>* 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.<br>* Other names: Breathe Right Nasal Srip;|
| Experimental: Oral appliance<br>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<br>* 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.<br>* Other names: Breathe Right nasal strip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the two treatment arms at treating sleep disordered breathing. |  | single night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the treatment arms at improving metabolic perturbations of GHTN. |  | single night | 
| Acceptability of therapy |  | single night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Disordered Breathing, Obstructive Sleep Apnea, Gestational Hypertension, Preeclampsia