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

NCT03309826 | Completed

• 1 other identifier: 2018-2856
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• PAP Adherence

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

  Through study completion, 8 weeks post-partum

Secondary Outcomes (9)

• Subject recruitment rates

  Through study completion, 8 weeks post-partum

• Subject retention rates

  Through study completion, 8 weeks post-partum

• Maternal 24 hour blood pressure

  Baseline, approximately one week prior to delivery and 8 weeks post-partum

• Maternal blood pressure

  Baseline, approximately one week prior to delivery and 8 weeks post-partum

• Arterial stiffness measured as carotid-femoral pulse wave velocity

  Baseline, approximately one week prior to delivery and 8 weeks post-partum

Study Arms (2)

PAP Treatment Arm

EXPERIMENTAL

Automated positive airway pressure titration then treatment with fixed PAP.

Device: Positive Airway Pressure

Nasal Dilator Strip

ACTIVE COMPARATOR

Nightly use of nasal dilator strip

Device: Nasal Dilator Strip

Interventions

Positive Airway Pressure DEVICE

Auto-PAP titration followed by fixed PAP treatment

Also known as: PAP

PAP Treatment Arm

Nasal Dilator Strip DEVICE

Nightly use of nasal dilator strip

Nasal Dilator Strip

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female gender defined by pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr John Kimoff: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• ResMed Canada Inc.: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (2)

• Smocot J, Huynh N, Panyarath P, Kimoff RJ, Meltzer S, Drouin-Gagne L, Newbold R, Hebert C, Benedetti A, Arcache JP, Morency AM, Garfield N, Rey E, Pamidi S. Patterns of adherence to continuous positive airway pressure and mandibular advancement splints in pregnant individuals with sleep-disordered breathing. Sleep Breath. 2025 Apr 4;29(2):148. doi: 10.1007/s11325-025-03284-5.

  PMID: 40183988 DERIVED

• Panyarath P, Goldscher N, Pamidi S, Daskalopoulou SS, Gagnon R, Dayan N, Raiche K, Olha A, Geater SL, Benedetti A, Kimoff RJ. Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Hypertensive Disorders of Pregnancy: A Pilot Randomized Proof-of-Concept Clinical Trial. Ann Am Thorac Soc. 2024 May;21(5):803-813. doi: 10.1513/AnnalsATS.202310-863OC.

  PMID: 38252423 DERIVED

MeSH Terms

Conditions

Toxemia; Sleep Apnea, Obstructive; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Infections; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John Kimoff, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis of all outcome measures will be conducted on a blinded basis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 16, 2017
• Study Start: October 16, 2017
• Primary Completion: July 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)