Sleep Disordered Breathing and Gestational Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing; Preeclampsia; Gestational Hypertension
• Intervention / Treatment: Device: CPAP; Device: Oral Appliance

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP treatment; 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; 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.; Other Names: Respironics M Series Autoset CPAP; Somnoguard AP oral apliance; Breathe Right Nasal Srip
Experimental: 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.	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.; Other Names: Somnoguard AP; Breathe Right nasal strip

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: John K Reid, MD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Estimate): September 9, 2009
• Last Update Submitted That Met QC Criteria: September 4, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Preeclampsia; Sleep Disordered Breathing; Gestational Hypertension
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pregnancy Complications; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Respiratory Aspiration; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: Bio: 08-21