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

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309826
• Other study ID #: 2018-2856
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2023
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Pregnancy Complications
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Toxemia

Intervention

Device:
• Positive Airway Pressure
Auto-PAP titration followed by fixed PAP treatment
• Nasal Dilator Strip
Nightly use of nasal dilator strip

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Dr John Kimoff	Canadian Institutes of Health Research (CIHR), ResMed Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAP Adherence	The proportion of subjects demonstrating >4h/night CPAP use by objective; microprocessor monitoring	Through study completion, 8 weeks post-partum
Secondary	Subject recruitment rates	Percent recruitment of eligible subjects	Through study completion, 8 weeks post-partum
Secondary	Subject retention rates	Number of subjects completing the study protocol	Through study completion, 8 weeks post-partum
Secondary	Maternal 24 hour blood pressure	24 hour ambulatory blood pressure	Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary	Maternal blood pressure	Standardized blood pressure measurements using "BPTru" device	Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary	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
Secondary	Epworth Sleepiness Score	Standard subjective sleepiness score	Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary	Pittsburgh Sleep Quality Index	Subjective sleep quality index	Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary	Restless leg syndrome questionnaire	International Restless Legs Study Group questionnaire	Baseline, approximately one week prior to delivery and 8 weeks post-partum
Secondary	Functional Outcomes of Sleep Questionnaire	Sleep-related quality of life questionnaire	Baseline, approximately one week prior to delivery and 8 weeks post-partum