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

Dr John Kimoff48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertensive Disorder of Pregnancy Sleep Apnea, Obstructive

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

PAP Adherence

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

Time frame: Through study completion, 8 weeks post-partum

Secondary Outcomes

Subject recruitment rates

Percent recruitment of eligible subjects

Time frame: Through study completion, 8 weeks post-partum

Subject retention rates

Number of subjects completing the study protocol

Time frame: Through study completion, 8 weeks post-partum

Maternal 24 hour blood pressure

24 hour ambulatory blood pressure