Status:
COMPLETED
Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of Pregnancy
Lead Sponsor:
Dr John Kimoff
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
ResMed Canada Inc.
Conditions:
Hypertensive Disorder of Pregnancy
Sleep Apnea, Obstructive
Eligibility:
FEMALE
18+ years
Phase:
NA
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 posti...
Eligibility Criteria
Inclusion
- ≥ 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
- 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)
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03309826
Start Date
October 16 2017
End Date
December 31 2021
Last Update
October 23 2023
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1