NCT03309826

Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of Pregnancy

Effects of Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing on Maternal and Fetal Outcomes in Hypertensive Disorders of Pregnancy: a Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr John Kimoff · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a pilot randomized, controlled trial to evaluate the feasibility and obtain pilot outcome data for a subsequent definitive trial evaluating the effects of postitive airway pressure (PAP) treatment of obstructive sleep-disordered breathing (OSDB) on blood pressure control and maternal and fetal outcomes in hypertensive disorders of pregnancy. The primary aim of the pilot study is to assess feasibility measured as the rates of subject recruitment, adequate (\>4h/night) PAP adherence (primary outcome measure) and protocol completion. Secondary aims will be to obtain preliminary data on the effects of PAP on maternal blood pressure, complications of hypertension, arterial stiffness and vascular biomarkers, course of labor and delivery and fetal outcomes including growth restriction, prematurity, and neonatal distress.

Conditions

• Hypertensive Disorder of Pregnancy
• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	Positive Airway Pressure	Auto-PAP titration followed by fixed PAP treatment
DEVICE	Nasal Dilator Strip	Nightly use of nasal dilator strip

Timeline

• Start date: 2017-10-16
• Primary completion: 2021-07-30
• Completion: 2021-12-31
• First posted: 2017-10-16
• Last updated: 2023-10-23

Locations

1 site across 1 country: Canada