N/A
N=186
Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
Sleep Disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT02191085 ↗Enrolled (actual)
186
Serious AEs
—
Results posted
Jul 2025
Primary outcome: Primary: Adherence to Positive Airway Pressure (PAP) Therapy — 4; 3.5 hours per night
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fast Track (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Calgary
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Positive Airway Pressure (PAP) Therapy |
5.56; 6.14 | — |
| SECONDARY Change in Daytime Sleepiness |
4.62; 1.79 | — |
| SECONDARY Health Care Utilization |
1960; 1670; 282; 219; 1410; 1760 | — |
| SECONDARY Total Healthcare Costs |
8572; 8203 | — |
| SECONDARY Time From Date of Referral to Date of Treatment Initiation |
134; 110 | — |
| SECONDARY Change in Daytime Sleepiness |
4.62; 1.79 | — |
| SECONDARY Adherence to Positive Airway Pressure (PAP) Therapy |
5.56; 6.14 | — |
| SECONDARY Change in Disease Specific Health-related Quality of Life |
0.99; 1.39 | — |
| SECONDARY Change in Disease Specific Health-related Quality of Life |
0.99; 1.39 | — |
| SECONDARY Patient Satisfaction |
34.54; 37.39 | — |
| SECONDARY Patient Satisfaction |
34.54; 37.39 | — |
| SECONDARY Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits |
57.2; 56.2; 649; 566; 182; 56.2 | — |
| SECONDARY Change in Severity of Sleep-disordered Breathing |
-46; -44 | — |
| SECONDARY Change in Severity of Sleep-disordered Breathing |
-46; -44 | — |
| SECONDARY Change in General Health-related Quality of Life |
0.15; 0.15 | — |
| SECONDARY Change in General Health-related Quality of Life |
0.15; 0.15 | — |
| SECONDARY Quality Adjusted Life Years |
0.587; 0.654 | — |
Summary
Access to medical care for patients with breathing disorders during sleep is a major problem for Canadians. Recently, there has been increasing interest in how health care providers who are not physicians can help to improve access to medical care for these patients, but it is unclear whether patients with severe sleep-disordered breathing who receive care from these non-physician providers have the same response to treatment as patients who receive care from physicians. Since these severe have a high risk of developing cardiac and respiratory complications and of being hospitalized, an initiative to improve access such as the use of non-physician providers could be of great benefit to individual patients and the health care system.
The objectives of this project are:
1. to determine whether patients with severe breathing disorders during sleep have the same response to treatment when cared for by non-physician health care providers (respiratory therapists) as they do when cared for by physicians;
2. to determine the effects of non-physician health care provider treatment to patient access;
3. to determine health care utilization and related costs associated with non-physician health care provider treatment.
Eligibility Criteria
Inclusion Criteria
- referred to the FMC Sleep Centre for assessment of SDB
- meet one of the three criteria for suspected severe SDB:
- Respiratory disturbance index (RDI) >/= 30 events/hour on an ambulatory sleep test
- Mean nocturnal oxygen saturation /= 15 events/hour on an ambulatory sleep test and partial pressure of carbon dioxide >/= 45 mmHg on arterial blood gas
- On supplemental oxygen therapy with high suspicion of SDB (as determined by physician review of referral)
Exclusion Criteria
- Suspected concomitant sleep disorder other than SDB
- A previous diagnosis of OSA treated with PAP or dental appliance
- Primary health insurance provided by a province other than Alberta
- Failure to provide consent to participate in the study
- Under the age of 18
Data sourced from ClinicalTrials.gov (NCT02191085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.