Sleep Disordered Breathing and Gestational Hypertension

Obstructive Sleep Apnea Clinical Trial

Official title:

Sleep Disordered Breathing and Gestational Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757718
• Other study ID #: Bio: 08-21
• Status: Completed
• Phase: N/A
• First received: September 22, 2008
• Last updated: September 4, 2009
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced
• Obstructive Sleep Apnea
• Pre-Eclampsia
• Preeclampsia
• Respiratory Aspiration
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

Intervention

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
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.

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the two treatment arms at treating sleep disordered breathing.		single night	No
Secondary	Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.		single night	No
Secondary	Acceptability of therapy		single night	No