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| Name | Class |
|---|---|
| Canadian Lung Association | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Management | Experimental | Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage |
|
| Usual Care | No Intervention | Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Management | Other | Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive airway pressure adherence | Mean number of hours of positive airway pressure use per night in the four weeks prior to three month follow-up | 3 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Positive airway pressure therapy initiation | Proportion of patients who initiate positive airway pressure therapy | 1 week after sleep physician visit |
| Adherent to positive airway pressure | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sachin Pendharkar | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre Sleep Centre | Calgary | Alberta | T2N 2T9 | Canada |
Deidentified data may be shared upon completion of data sharing agreement
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Data will be available 1 year after initial results are published.
Please contact principal investigator with study proposal
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 3 months after treatment initiation |
| Sleepiness | Change in Epworth Sleepiness Scale score from baseline to three months. Scale is from 0-24 with higher scores indicating greater sleepiness | 3 months after treatment initiation |
| General health-related quality of life: Change in EuroQoL-5D-3L | 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 | 3 months after treatment initiation |
| Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index | 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 | 3 months after treatment initiation |
| Patient satisfaction: Visit-Specific Satisfaction Instrument total score | 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 | 3 months after treatment initiation |
| Patient activation | Change in Patient Activation Measure score from baseline to three months. Scale is from 0-100 with higher scores indicating greater activation | 3 months after treatment initiation |
| Patient activation level | 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 | 3 months after treatment initiation |
| Self-efficacy: Self-Efficacy Measure for Sleep Apnea score | 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 | 3 months after treatment initiation |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |