Clinical Trials Directory

Trials / Completed

CompletedNCT00259688

Prevalence Study of Sleep Apnea in Women With Preeclampsia

Sleep Disordered Breathing and Preeclampsia

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
University of Saskatchewan · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

Hypothesis: The prevalence of sleep apnea is greater in pregnant women with preeclampsia than in pregnant women without preeclampsia.The presence of sleep apnea will be associated with poor blood pressure control, worsening blood pressure during sleep and evidence of fetal distress. The usual treatment for sleep apnea is to have the patient breathe pressurized air through a mask. This is called continuous positive airway pressure (CPAP). In preeclamptic women with sleep apnea, use of CPAP will result in improved blood pressure control and reduced fetal distress.

Detailed description

Sleep apnea is common in the adult population. In middle aged men, the presence of sleep apnea has been correlated with hypertension, cardiovascular disease and mood disorders. Sleep apnea is not as well studied in women and even less is known about sleep apnea in pregnant women. However, preliminary evidence suggests that the incidence is quite high, particularly in women with severe preeclampsia. We propose to perform sleep studies on 30 women with preeclampsia and 30 healthy pregnant controls. In addition to the usual sleep study monitoring, we will also measure beat-to-beat blood pressure through non-invasive monitoring and we will do continuous electronic fetal monitoring. Women found to have sleep apnea will have a repeat study in which CPAP therapy is applied, and be provided CPAP therapy for nightly use at home.

Conditions

Interventions

TypeNameDescription
DEVICECPAP therapy for subjects diagnosed with sleep apneaCPAP therapy is being offered to women who are diagnosed on Polysomnogram with sleep apnea. However, this is not an intervention study and treatment is not part of the study protocol.

Timeline

Start date
2006-02-01
Primary completion
2009-10-01
Completion
2009-11-01
First posted
2005-11-29
Last updated
2010-01-08

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00259688. Inclusion in this directory is not an endorsement.