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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertensive Disorder of Pregnancy Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Analysis of all outcome measures will be conducted on a blinded basis.

Study Groups

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PAP Treatment Arm

Automated positive airway pressure titration then treatment with fixed PAP.

Group Type EXPERIMENTAL

Positive Airway Pressure

Intervention Type DEVICE

Auto-PAP titration followed by fixed PAP treatment

Nasal Dilator Strip

Nightly use of nasal dilator strip

Group Type ACTIVE_COMPARATOR

Nasal Dilator Strip

Intervention Type DEVICE

Nightly use of nasal dilator strip

Interventions

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Positive Airway Pressure

Auto-PAP titration followed by fixed PAP treatment

Intervention Type DEVICE

Nasal Dilator Strip

Nightly use of nasal dilator strip

Intervention Type DEVICE

Other Intervention Names

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PAP

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No