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NCT Number: NCT03309826

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

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.

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Key information

Conditions

Hypertensive Disorder of Pregnancy Apnea Cardiovascular Diseases Dyssomnias Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Infections Nervous System Diseases Pre-Eclampsia Pregnancy Complications Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Toxemia Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Positive Airway Pressure

Device

Auto-PAP titration followed by fixed PAP treatment

Other names: PAP

Nasal Dilator Strip

Device

Nightly use of nasal dilator strip

Primary outcomes

  1. PAP Adherence

    Time frame: Through study completion, 8 weeks post-partum

    The proportion of subjects demonstrating >4h/night CPAP use by objective; microprocessor monitoring

Secondary outcomes

  1. Subject recruitment rates

    Time frame: Through study completion, 8 weeks post-partum

    Percent recruitment of eligible subjects

  2. Subject retention rates

    Time frame: Through study completion, 8 weeks post-partum

    Number of subjects completing the study protocol

  3. Maternal 24 hour blood pressure

    Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum

    24 hour ambulatory blood pressure

  4. Maternal blood pressure

    Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum

    Standardized blood pressure measurements using "BPTru" device

  5. Arterial stiffness measured as carotid-femoral pulse wave velocity

    Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum

    Non-invasive measurement of arterial stiffness using applanation tonometry

  6. Epworth Sleepiness Score

    Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum

    Standard subjective sleepiness score

  7. Pittsburgh Sleep Quality Index

    Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum

    Subjective sleep quality index

  8. Restless leg syndrome questionnaire

    Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum

    International Restless Legs Study Group questionnaire

  9. Functional Outcomes of Sleep Questionnaire

    Time frame: Baseline, approximately one week prior to delivery and 8 weeks post-partum

    Sleep-related quality of life questionnaire

Sponsors and collaborators

Lead sponsor

Dr John Kimoff

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • ResMed Canada Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 16, 2017
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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