Sleep Disordered Breathing and Gestational Hypertension

Not Applicable

Completed

• Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea; Gestational Hypertension; Preeclampsia
• Interventions: Device: CPAP; Device: Oral Appliance

• Registration Number: NCT00757718
• Lead Sponsor: University of Saskatchewan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Study Start: 2008-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-04
• Last Update Posted: 2009-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP treatment	CPAP	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.
Oral appliance	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.

Primary Outcome Measures

Name	Time	Method
Effectiveness of the two treatment arms at treating sleep disordered breathing.	single night

Secondary Outcome Measures

Name	Time	Method
Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.	single night
Acceptability of therapy	single night

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada