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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| ResMed Canada Inc. | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAP Treatment Arm | Experimental | Automated positive airway pressure titration then treatment with fixed PAP. |
|
| Nasal Dilator Strip | Active Comparator | Nightly use of nasal dilator strip |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure | Device | Auto-PAP titration followed by fixed PAP treatment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female gender defined by pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| John Kimoff, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40183988 | Derived | 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. | |
| 38252423 |
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| ID | Term |
|---|---|
| D014115 | Toxemia |
| D020181 | Sleep Apnea, Obstructive |
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| D004461 | Eclampsia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
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Analysis of all outcome measures will be conducted on a blinded basis.
| Nasal Dilator Strip | Device | Nightly use of nasal dilator strip |
|
| 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 |
| 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. |
| D012140 |
| Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |