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Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of Pregnancy | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT03309826•Dr John Kimoff

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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)

Locations (1)

McGill University Health Centre

Montreal, Quebec, Canada

Key Dates

Start Date

October 16, 2017

Primary Completion Date

July 30, 2021

Completion Date

December 31, 2021

Last Updated

October 23, 2023

Enrollment

ACTUAL participants

Conditions

Hypertensive Disorder of PregnancySleep Apnea, Obstructive

Interventions

Positive Airway Pressure

DEVICE

Nasal Dilator Strip

DEVICE

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

NCT07446634

Sleep Apnea, Obstructive

View study

RECRUITINGNA

Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy

NCT05999851

PreeclampsiaHypertensive Disorder of Pregnancy

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy

HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring

Long-term Evaluation of a Nasopharyngeal Airway

Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea

Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea