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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Hypertensive Disorder of Pregnancy
• Intervention / Treatment: Device: Positive Airway Pressure; Device: Nasal Dilator Strip

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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
Experimental: PAP Treatment Arm; Automated positive airway pressure titration then treatment with fixed PAP.	Device: Positive Airway Pressure; Auto-PAP titration followed by fixed PAP treatment; Other Names: PAP
Active Comparator: Nasal Dilator Strip; Nightly use of nasal dilator strip	Device: Nasal Dilator Strip; Nightly use of nasal dilator strip

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr John Kimoff
• Collaborators: Canadian Institutes of Health Research (CIHR); ResMed Canada Inc.
• Investigators: Principal Investigator: John Kimoff, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: polysomnography; blood pressure; arterial stiffness; pre-eclampsia; eclampsia; positive airway pressure; gestational hypertension; obstructive sleep apnea-hypopnea
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Infections; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Toxemia; Hypertension; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: 2018-2856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No