ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03309826
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
ResMed Canada Inc.
Information provided by (Responsible Party):
Dr John Kimoff, McGill University

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.

Condition or disease Intervention/treatment Phase
Hypertensive Disorder of Pregnancy Sleep Apnea, Obstructive Device: Positive Airway Pressure Device: Nasal Dilator Strip Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Analysis of all outcome measures will be conducted on a blinded basis.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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 Name: PAP

Active Comparator: Nasal Dilator Strip
Nightly use of nasal dilator strip
Device: Nasal Dilator Strip
Nightly use of nasal dilator strip




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female gender defined by pregnancy
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309826


Contacts
Contact: John Kimoff, MD 514-934-1934 ext 35946 john.kimoff@mcgill.ca
Contact: Sushmita Pamidi, MD 514-934-1934 ext 32215 sushmita.pamidi@mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: John Kimoff    514-934-1934 ext 36479    john.kimoff@mcgill.ca   
Sponsors and Collaborators
Dr John Kimoff
Canadian Institutes of Health Research (CIHR)
ResMed Canada Inc.
Investigators
Principal Investigator: John Kimoff, MD McGill University Health Center

Responsible Party: Dr John Kimoff, Professor of Medicine, McGill University
ClinicalTrials.gov Identifier: NCT03309826     History of Changes
Other Study ID Numbers: 2018-2856
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr John Kimoff, McGill University:
gestational hypertension
pre-eclampsia
eclampsia
obstructive sleep apnea-hypopnea
positive airway pressure
polysomnography
blood pressure
arterial stiffness

Additional relevant MeSH terms:
Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertension
Pregnancy Complications
Pre-Eclampsia
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced