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

Not Applicable

Completed

• Conditions: Hypertensive Disorder of Pregnancy; Sleep Apnea, Obstructive
• Interventions: Device: Positive Airway Pressure; Device: Nasal Dilator Strip

• Registration Number: NCT03309826
• Lead Sponsor: Dr John Kimoff

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-10-10
• Study Start: 2017-10-16
• Study First Posted: 2017-10-16
• Primary Completion: 2021-07-30
• Study Completion: 2021-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• ≥ 18 y with a singleton pregnancy, ≥ 12 weeks' gestation
• diagnosis of hypertensive disorder of pregnancy, including pre-existing hypertension, gestational hypertension and pre-eclampsia, as defined by Canadian Hypertensive Disorders of Pregnancy Working Group Criteria (Magee et al; Best Practice and Research Clinical obstetrics & Gynaecology. 2015;29(5):643-657)
• presence of obstructive sleep-disordered breathing (OSDB) on a single night in-home complete (Level 2) polysomnogram defined by an apnea-hypopnea index (AHI) ≥ 5 events/h and/or the presence of inspiratory flow limitation on ≥ 30% of breaths.

Exclusion Criteria

• severe pre-eclampsia/eclampsia requiring urgent delivery
• chronic kidney disease or other secondary cause of hypertension
• known cardiac disease, transient ischemic attack/stroke
• malignancy or other chronic medical or psychiatric condition
• smoking, alcohol use, illicit drugs
• current/recent treatment for sleep-disordered breathing
• severe sleep-disordered breathing defined as an apnea-hypopnea index (AHI) ≥ 30/h with either severe sleepiness (Epworth sleepiness score ≥ 15) or hypoxemia (4% Oxygen Desaturation Index ≥30/h or arterial oxygen saturation (SpO2) <80% for >10% of Total Sleep Time)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAP Treatment Arm	Positive Airway Pressure	Automated positive airway pressure titration then treatment with fixed PAP.
Nasal Dilator Strip	Nasal Dilator Strip	Nightly use of nasal dilator strip

Primary Outcome Measures

Name	Time	Method
PAP Adherence	Through study completion, 8 weeks post-partum	The proportion of subjects demonstrating \>4h/night CPAP use by objective; microprocessor monitoring

Secondary Outcome Measures

Name	Time	Method
Subject retention rates	Through study completion, 8 weeks post-partum	Number of subjects completing the study protocol
Subject recruitment rates	Through study completion, 8 weeks post-partum	Percent recruitment of eligible subjects
Maternal blood pressure	Baseline, approximately one week prior to delivery and 8 weeks post-partum	Standardized blood pressure measurements using "BPTru" device
Pittsburgh Sleep Quality Index	Baseline, approximately one week prior to delivery and 8 weeks post-partum	Subjective sleep quality index
Maternal 24 hour blood pressure	Baseline, approximately one week prior to delivery and 8 weeks post-partum	24 hour ambulatory blood pressure
Arterial stiffness measured as carotid-femoral pulse wave velocity	Baseline, approximately one week prior to delivery and 8 weeks post-partum	Non-invasive measurement of arterial stiffness using applanation tonometry
Epworth Sleepiness Score	Baseline, approximately one week prior to delivery and 8 weeks post-partum	Standard subjective sleepiness score
Restless leg syndrome questionnaire	Baseline, approximately one week prior to delivery and 8 weeks post-partum	International Restless Legs Study Group questionnaire
Functional Outcomes of Sleep Questionnaire	Baseline, approximately one week prior to delivery and 8 weeks post-partum	Sleep-related quality of life questionnaire

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada