Hypertensive Disorder of Pregnancy, Sleep Apnea, Obstructive
Conditions
Keywords
gestational hypertension, pre-eclampsia, eclampsia, obstructive sleep apnea-hypopnea, positive airway pressure, polysomnography, blood pressure, arterial stiffness
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.
Interventions
DEVICEPositive Airway Pressure
Auto-PAP titration followed by fixed PAP treatment
DEVICENasal Dilator Strip
Nightly use of nasal dilator strip
Sponsors
Canadian Institutes of Health Research (CIHR)
ResMed Canada Inc.
Dr John Kimoff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Analysis of all outcome measures will be conducted on a blinded basis.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAP Adherence | Through study completion, 8 weeks post-partum | The proportion of subjects demonstrating \>4h/night CPAP use by objective; microprocessor monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject retention rates | Through study completion, 8 weeks post-partum | Number of subjects completing the study protocol |
| Maternal 24 hour blood pressure | Baseline, approximately one week prior to delivery and 8 weeks post-partum | 24 hour ambulatory blood pressure |
| Maternal blood pressure | Baseline, approximately one week prior to delivery and 8 weeks post-partum | Standardized blood pressure measurements using BPTru device |
| Arterial stiffness measured as carotid-femoral pulse wave velocity | Baseline, approximately one week prior to delivery and 8 weeks post-partum | Non-invasive measurement of arterial stiffness using applanation tonometry |
| Subject recruitment rates | Through study completion, 8 weeks post-partum | Percent recruitment of eligible subjects |
| Pittsburgh Sleep Quality Index | Baseline, approximately one week prior to delivery and 8 weeks post-partum | Subjective sleep quality index |
| Restless leg syndrome questionnaire | Baseline, approximately one week prior to delivery and 8 weeks post-partum | International Restless Legs Study Group questionnaire |
| Functional Outcomes of Sleep Questionnaire | Baseline, approximately one week prior to delivery and 8 weeks post-partum | Sleep-related quality of life questionnaire |
| Epworth Sleepiness Score | Baseline, approximately one week prior to delivery and 8 weeks post-partum | Standard subjective sleepiness score |
Countries
Canada
Outcome results
None listed