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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03309826
Other study ID # 2018-2856
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2017
Est. completion date December 31, 2021

Study information

Verified date October 2023
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 31, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Positive Airway Pressure
Auto-PAP titration followed by fixed PAP treatment
Nasal Dilator Strip
Nightly use of nasal dilator strip

Locations

Country Name City State
Canada McGill University Health Centre Montreal Quebec

Sponsors (3)

Lead Sponsor Collaborator
Dr John Kimoff Canadian Institutes of Health Research (CIHR), ResMed Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary PAP Adherence The proportion of subjects demonstrating >4h/night CPAP use by objective; microprocessor monitoring Through study completion, 8 weeks post-partum
Secondary Subject recruitment rates Percent recruitment of eligible subjects Through study completion, 8 weeks post-partum
Secondary Subject retention rates Number of subjects completing the study protocol Through study completion, 8 weeks post-partum
Secondary Maternal 24 hour blood pressure 24 hour ambulatory blood pressure Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary Maternal blood pressure Standardized blood pressure measurements using "BPTru" device Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary 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
Secondary Epworth Sleepiness Score Standard subjective sleepiness score Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary Pittsburgh Sleep Quality Index Subjective sleep quality index Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary Restless leg syndrome questionnaire International Restless Legs Study Group questionnaire Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary Functional Outcomes of Sleep Questionnaire Sleep-related quality of life questionnaire Baseline, approximately one week prior to delivery and 8 weeks post-partum
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