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

Primary Purpose

Hypertensive Disorder of Pregnancy, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Positive Airway Pressure
Nasal Dilator Strip
Sponsored by
Dr John Kimoff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Disorder of Pregnancy focused on measuring gestational hypertension, pre-eclampsia, eclampsia, obstructive sleep apnea-hypopnea, positive airway pressure, polysomnography, blood pressure, arterial stiffness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PAP Treatment Arm

Nasal Dilator Strip

Arm Description

Automated positive airway pressure titration then treatment with fixed PAP.

Nightly use of nasal dilator strip

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subject recruitment rates
Percent recruitment of eligible subjects
Subject retention rates
Number of subjects completing the study protocol
Maternal 24 hour blood pressure
24 hour ambulatory blood pressure
Maternal blood pressure
Standardized blood pressure measurements using "BPTru" device
Arterial stiffness measured as carotid-femoral pulse wave velocity
Non-invasive measurement of arterial stiffness using applanation tonometry
Epworth Sleepiness Score
Standard subjective sleepiness score
Pittsburgh Sleep Quality Index
Subjective sleep quality index
Restless leg syndrome questionnaire
International Restless Legs Study Group questionnaire
Functional Outcomes of Sleep Questionnaire
Sleep-related quality of life questionnaire

Full Information

First Posted
September 25, 2017
Last Updated
October 20, 2023
Sponsor
Dr John Kimoff
Collaborators
Canadian Institutes of Health Research (CIHR), ResMed Canada Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03309826
Brief Title
Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of Pregnancy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr John Kimoff
Collaborators
Canadian Institutes of Health Research (CIHR), ResMed Canada Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorder of Pregnancy, Sleep Apnea, Obstructive
Keywords
gestational hypertension, pre-eclampsia, eclampsia, obstructive sleep apnea-hypopnea, positive airway pressure, polysomnography, blood pressure, arterial stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Analysis of all outcome measures will be conducted on a blinded basis.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PAP Treatment Arm
Arm Type
Experimental
Arm Description
Automated positive airway pressure titration then treatment with fixed PAP.
Arm Title
Nasal Dilator Strip
Arm Type
Active Comparator
Arm Description
Nightly use of nasal dilator strip
Intervention Type
Device
Intervention Name(s)
Positive Airway Pressure
Other Intervention Name(s)
PAP
Intervention Description
Auto-PAP titration followed by fixed PAP treatment
Intervention Type
Device
Intervention Name(s)
Nasal Dilator Strip
Intervention Description
Nightly use of nasal dilator strip
Primary Outcome Measure Information:
Title
PAP Adherence
Description
The proportion of subjects demonstrating >4h/night CPAP use by objective; microprocessor monitoring
Time Frame
Through study completion, 8 weeks post-partum
Secondary Outcome Measure Information:
Title
Subject recruitment rates
Description
Percent recruitment of eligible subjects
Time Frame
Through study completion, 8 weeks post-partum
Title
Subject retention rates
Description
Number of subjects completing the study protocol
Time Frame
Through study completion, 8 weeks post-partum
Title
Maternal 24 hour blood pressure
Description
24 hour ambulatory blood pressure
Time Frame
Baseline, approximately one week prior to delivery and 8 weeks post-partum
Title
Maternal blood pressure
Description
Standardized blood pressure measurements using "BPTru" device
Time Frame
Baseline, approximately one week prior to delivery and 8 weeks post-partum
Title
Arterial stiffness measured as carotid-femoral pulse wave velocity
Description
Non-invasive measurement of arterial stiffness using applanation tonometry
Time Frame
Baseline, approximately one week prior to delivery and 8 weeks post-partum
Title
Epworth Sleepiness Score
Description
Standard subjective sleepiness score
Time Frame
Baseline, approximately one week prior to delivery and 8 weeks post-partum
Title
Pittsburgh Sleep Quality Index
Description
Subjective sleep quality index
Time Frame
Baseline, approximately one week prior to delivery and 8 weeks post-partum
Title
Restless leg syndrome questionnaire
Description
International Restless Legs Study Group questionnaire
Time Frame
Baseline, approximately one week prior to delivery and 8 weeks post-partum
Title
Functional Outcomes of Sleep Questionnaire
Description
Sleep-related quality of life questionnaire
Time Frame
Baseline, approximately one week prior to delivery and 8 weeks post-partum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female gender defined by pregnancy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kimoff, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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