Sleep Disordered Breathing and Gestational Hypertension

NCT00757718 | Completed

• 1 other identifier: Bio: 08-21
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the two treatment arms at treating sleep disordered breathing.

  single night

Secondary Outcomes (2)

• Effectiveness of the treatment arms at improving metabolic perturbations of GHTN.

  single night

• Acceptability of therapy

  single night

Study Arms (2)

CPAP treatment

ACTIVE COMPARATOR

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

Oral appliance

EXPERIMENTAL

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

Interventions

CPAP DEVICE

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.

Also known as: Respironics M Series Autoset CPAP, Somnoguard AP oral apliance, Breathe Right Nasal Srip

CPAP treatment

Oral Appliance DEVICE

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.

Also known as: Somnoguard AP, Breathe Right nasal strip

Oral appliance

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with singleton pregnancies who have the diagnosis of gestational hypertension.

You may not qualify if:

• Inability to comply with study parameters
• Delivery expected within 48 hours

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John K Reid, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 9, 2009

Record last verified: 2009-09

Locations

CA (1)