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

Study Overview
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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.

Official Title
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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

Conditions
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Hypertensive Disorder of Pregnancy, Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Positive Airway Pressure
* Device: Nasal Dilator Strip


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAP Treatment Arm<br>Automated positive airway pressure titration then treatment with fixed PAP. | Device: Positive Airway Pressure<br>* Auto-PAP titration followed by fixed PAP treatment<br>* Other names: PAP;|
| Active Comparator: Nasal Dilator Strip<br>Nightly use of nasal dilator strip | Device: Nasal Dilator Strip<br>* Nightly use of nasal dilator strip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAP Adherence | The proportion of subjects demonstrating >4h/night CPAP use by objective; microprocessor monitoring | Through study completion, 8 weeks post-partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject recruitment rates | Percent recruitment of eligible subjects | Through study completion, 8 weeks post-partum | 
| Subject retention rates | Number of subjects completing the study protocol | Through study completion, 8 weeks post-partum | 
| Maternal 24 hour blood pressure | 24 hour ambulatory blood pressure | Baseline, approximately one week prior to delivery and 8 weeks post-partum | 
| Maternal blood pressure | Standardized blood pressure measurements using BPTru device | Baseline, approximately one week prior to delivery and 8 weeks post-partum | 
| 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 | 
| Epworth Sleepiness Score | Standard subjective sleepiness score | Baseline, approximately one week prior to delivery and 8 weeks post-partum | 
| Pittsburgh Sleep Quality Index | Subjective sleep quality index | Baseline, approximately one week prior to delivery and 8 weeks post-partum | 
| Restless leg syndrome questionnaire | International Restless Legs Study Group questionnaire | Baseline, approximately one week prior to delivery and 8 weeks post-partum | 
| Functional Outcomes of Sleep Questionnaire | Sleep-related quality of life questionnaire | Baseline, approximately one week prior to delivery and 8 weeks post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational hypertension, pre-eclampsia, eclampsia, obstructive sleep apnea-hypopnea, positive airway pressure, polysomnography, blood pressure, arterial stiffness