Obstructive Sleep Apnea
Conditions
Keywords
Access to Health Care, Time to Treatment, Treatment Adherence, Quality of Care
Brief summary
The primary objective of this study is to evaluate the effect of more timely care for obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy at three months after treatment initiation. The secondary objectives are to determine if earlier care improves the treatment effect of PAP on patient reported sleepiness, quality of life and patient satisfaction. We will also evaluate the impact of shorter wait times on patient engagement in therapy by assessing initial acceptance of PAP therapy, patient activation and self-efficacy with respect to OSA treatment. The study hypothesis is that the early management strategy will be superior to usual care with respect to the primary outcome of PAP adherence at three months.
Interventions
OTHEREarly Management
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
Sponsors
University of Calgary
Canadian Lung Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HSAT ODI \>= events/hr and ESS 10 - 15 OR * HSAT ODI 15 - 30 and ESS 15 or lower
Exclusion criteria
* Severe nocturnal hypoxemia on HSAT (mean oxygen saturation by pulse oximetry (SpO2) ≤ 85%) * Severe hypersomnolence (Epworth Sleepiness Scale score ≥ 16) * Employed in safety-critical occupation * Recent motor vehicle collision reported on screening questionnaire (within one year) * Severe hypertension requiring ≥ three antihypertensive medications * Recent admission to hospital due to unstable cardiopulmonary disease (within 30 days) * Upcoming major surgery (within six months) * Prior history of OSA treatment * Significant co-morbid sleep disorder that would interfere with PAP acclimatization and adherence (e.g., severe insomnia, restless leg syndrome)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive airway pressure adherence | 3 months after treatment initiation | Mean number of hours of positive airway pressure use per night in the four weeks prior to three month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive airway pressure therapy initiation | 1 week after sleep physician visit | Proportion of patients who initiate positive airway pressure therapy |
| Adherent to positive airway pressure | 3 months after treatment initiation | Proportion of patients using positive airway pressure therapy for at least four hours per night on at least 70% of nights during the four weeks prior to the three-month follow-up |
| Sleepiness | 3 months after treatment initiation | Change in Epworth Sleepiness Scale score from baseline to three months. Scale is from 0-24 with higher scores indicating greater sleepiness |
| General health-related quality of life: Change in EuroQoL-5D-3L | 3 months after treatment initiation | Change in EuroQoL-5D-3L index score (0-1, higher scores indicating greater quality of life), dimensions (problem vs no problem) and visual analogue score (0-100, higher score indicating greater quality of life) from baseline to three months |
| Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index | 3 months after treatment initiation | Change in Sleep Apnea Quality of Life Index from baseline to three months. Scale includes four domains scored from 1-7, with higher scores indicating greater quality of life. The overall score is the average from the four domains |
| Patient satisfaction: Visit-Specific Satisfaction Instrument total score | 3 months after treatment initiation | Visit-Specific Satisfaction Instrument total score compared between groups at baseline and after three months of PAP therapy. Scale includes 9 questions rated from 1-5. Total score is between 9-45 with higher scores indicating greater satisfaction |
| Patient activation | 3 months after treatment initiation | Change in Patient Activation Measure score from baseline to three months. Scale is from 0-100 with higher scores indicating greater activation |
| Patient activation level | 3 months after treatment initiation | Change in patient activation level (based on Patient Activation Measure) from baseline to three months. Scale is from 0-100. Participants are classified from activation level 1-4 based on overall score, with higher level indicating greater activation |
| Self-efficacy: Self-Efficacy Measure for Sleep Apnea score | 3 months after treatment initiation | Self-Efficacy Measure for Sleep Apnea score compared between groups at baseline and after three months of PAP therapy. There are 3 subscales (risk perception, outcome expectancies, treatment self-efficacy), each scored from 1-4 with higher scores indicating greater self-efficacy |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORSachin Pendharkar
University of Calgary
Outcome results
None listed