NCT00757718

Sleep Disordered Breathing and Gestational Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disordered Breathing
• Obstructive Sleep Apnea
• Gestational Hypertension
• Preeclampsia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-09-23
• Last updated: 2009-09-09

Locations

1 site across 1 country: Canada