Clinical trial NCT03309826: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: ResMed Canada Inc.
First posted: 2017-10-16
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: PAP Adherence
timeFrame: Through study completion, 8 weeks post-partum
Secondary outcomes:
measure: Subject recruitment rates
timeFrame: Through study completion, 8 weeks post-partum
measure: Subject retention rates
timeFrame: Through study completion, 8 weeks post-partum
measure: Maternal 24 hour blood pressure
timeFrame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
measure: Maternal blood pressure
timeFrame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
measure: Arterial stiffness measured as carotid-femoral pulse wave velocity
timeFrame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
measure: Epworth Sleepiness Score
timeFrame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
measure: Restless leg syndrome questionnaire
timeFrame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
measure: Functional Outcomes of Sleep Questionnaire
timeFrame: Baseline, approximately one week prior to delivery and 8 weeks post-partum
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: John Kimoff, MD
role: PRINCIPAL_INVESTIGATOR
References: