Sleep Disordered BreathingNCT02191085
Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
A study testing Fast Track in people with Sleep Disordered Breathing, run by University of Calgary at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing
- What is being tested?
- Fast Track
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 </= 85% on an ambulatory sleep test
- Suspected hypoventilation, defined by an RDI >/= 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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;
- to determine the effects of non-physician health care provider treatment to patient access;
- to determine health care utilization and related costs associated with non-physician health care provider treatment.
Read the detailed description
The difficulty in providing timely access to sleep specialists is widespread. These delays are particularly important for patients with severe sleep-disordered breathing (SDB) due to the increased risk of adverse clinical outcomes and potential associated healthcare costs. The lack of timely access has sparked an interest in the use of alternate care providers (ACPs) to manage patients with SDB. Our group and others have demonstrated that ACPs are an effective and efficient substitute for physicians for patients with uncomplicated SDB. However, the role of ACPs in the management of patients with severe SDB remains unclear.
Prompted by wait times that far exceed current Canadian guidelines, we have recently implemented an ACP-led "Fast Track" clinic for patients who are referred to the Foothills Medical Centre (FMC) Sleep Centre with suspected severe SDB. In this clinic, patients with suspected severe SDB are assessed by a sleep-trained registered respiratory therapist functioning as an ACP. Decisions regarding further sleep testing and treatment are made by the patient and ACP, under the guidance of a sleep physician. This model of care differs from a physician-led model that is used at the FMC Sleep Centre.
To evaluate this novel care delivery model, we have designed a randomized trial comparing outcomes for patients in the "Fast Track" clinic to those who undergo conventional, physician-led care. The specific goals of this study are:
- to compare the clinical effectiveness of an ACP-led clinic for patients with suspected severe SDB to physician-led management;
- to determine whether cycle times from referral to diagnosis and treatment for patients referred with suspected severe SDB can be reduced by an ACP-led clinic;
- to determine the impact of an ACP-led clinic on the demand for sleep physicians, ACPs and diagnostic testing;
- to compare the cost-effectiveness of these models of care using data on healthcare utilization, costs, and patient reported health-related quality of life (HRQOL).
Patients in the "Standard Management" arm will be assessed by a sleep respirologist and follow a management plan that is determined by the sleep physician and patient. This plan may involve polysomnography or the initiation of positive airway pressure (PAP) therapy. If further testing is ordered, follow-up may occur with the physician or with an ACP, at the physician's discretion. For patients initiating PAP therapy, the decision to delegate follow-up to an ACP will be left up to the physician, as the intent of this study is to observe real-world practice and not to change the management of individual patients.
In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. To ensure patient safety, the management plan will be discussed with a sleep respirologist, who will be designated as the patient's primary sleep physician. This sleep physician will be available at the FMC Sleep Centre during the "Fast Track" clinic to assist with the assessment of patients who appear unwell (e.g. severe hypoxemia, decompensated cardiorespiratory failure, etc.). As in the "Standard Management" arm, follow-up visits to review test results, discuss and initiate treatment, or to assess treatment response may occur with the ACP who performed the initial assessment or may be delegated to any other ACP.
As is usual procedure at the FMC Sleep Centre, ambulatory sleep test requisitions will be completed by ACPs or physicians, whereas all polysomnogram requisitions will be completed by the primary sleep physician to ensure adequate blinding of patient assignment. The research associate will ensure that all tests are interpreted in advance of clinic visits. Patients who are followed by ACPs in either arm can be referred to the primary sleep physician for assessment of non-respiratory sleep disorders, or for persistent symptoms such as daytime sleepiness.
- Conditions
- Sleep Disordered Breathing
- Being tested
- Fast Track
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast TrackProcedure or surgery
In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. To ensure patient safety, the management plan will be discussed with a sleep respirologist, who will be designated as the patient's primary sleep physician. This sleep physician will be available at the FMC Sleep Centre during the "Fast Track" clinic to assist with the assessment of patients who appear unwell. As in the "Standard Management" arm, follow-up visits to review test results, discuss and initiate treatment, or to assess treatment response may occur with the ACP who performed the initial assessment or may be delegated to any other ACP.
| Study group | Role | What they receive |
|---|---|---|
| Standard Management | No intervention | Patients in the "Standard Management" arm will be assessed without any interventions.Patients will be assessed by a sleep respirologist and follow a management plan that is determined by the sleep physician and patient. This plan may involve polysomnography or the initiation of PAP therapy. If further testing is ordered, follow-up may occur with the physician or with an ACP, at the physician's discretion. For patients initiating PAP therapy, the decision to delegate follow-up to an ACP will be left up to the physician, as the intent of this study is to observe real-world practice and not to change the management of individual patients. |
| Fast Track | Active comparator | In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Receives: Procedure: Fast Track |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Positive Airway Pressure (PAP) Therapy
Data includes number of hours used per night on all nights
Measured: 3 months after treatment initiation
Secondary outcomes (16)
Change in Daytime Sleepiness
Epworth Sleepiness Scale - this is a subjective scale measuring tendency for an individual to fall asleep in 8 different circumstances. Score is 0-3 for each circumstance but is reported as a total score.
Minimum total score = 0, Maximum total score = 24 Higher scores mean worse outcome
Measured: 3 months after treatment initiation
Health Care Utilization
Costs for physician visits, emergency department visits, hospitalizations
Measured: 1 year after treatment initiation
Total Healthcare Costs
Comparing costs for each arm (used to calculate the incremental cost effectiveness ratio)
Measured: 1 year after treatment initiation
Time From Date of Referral to Date of Treatment Initiation
Comparing cycle times for intervention vs. control arm
Measured: Expected within 1 year (unknown due to nature of outcome)
Change in Daytime Sleepiness
Epworth Sleepiness Scale - a subjective scale measuring tendency for an individual to fall asleep in 8 different circumstances. Total score is sum of score in each circumstance (0-3) Minimum total score = 0, Maximum total score = 24 Higher scores mean worse outcome
Measured: 1 year after treatment initiation
Adherence to Positive Airway Pressure (PAP) Therapy
Data includes number of hours used per night.
Measured: 1 year after treatment initiation
Change in Disease Specific Health-related Quality of Life
Sleep Apnea Quality of Life Index - subjective disease-specific quality of life scale, incorporating 4 domains measured pre/post intervention (scored 1-7 on a Likert scale) and 3 post-intervention domains that are weighted before incorporated in the final score Minimum = 1 Maximum = 7 Higher scores indicate a better outcome
Measured: 3 months after treatment initiation
Change in Disease Specific Health-related Quality of Life
Sleep Apnea Quality of Life Index - subjective disease-specific quality of life scale, incorporating 4 domains measured pre/post intervention (scored 1-7 on a Likert scale) and 3 post-intervention domains that are weighted before incorporated in the final score Minimum = 1 Maximum = 7 Higher scores indicate a better outcome
Measured: 1 year after treatment initiation
Patient Satisfaction
Visit-Specific Instrument (VSQ-9) - comprises 9 questions for which patients assign a Likert scale score from 0-5. Score is reported as sum of Likert scale score for each question 0 to 45 scale Higher scores mean a better outcome.
Measured: 3 months after treatment initiation
Patient Satisfaction
Visit-Specific Instrument (VSQ-9) - comprises 9 questions for which patients assign a Likert scale score from 0-5. Score is reported as sum of Likert scale score for each question 0 to 45 scale Higher scores mean a better outcome.
Measured: 1 year after treatment initiation
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits
Reported as costs for home sleep apnea tests, polysomnograms, new and follow-up clinical visits
Measured: 1 year after treatment initiation
Change in Severity of Sleep-disordered Breathing
Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months
Measured: baseline and 3 months after treatment initiation
Change in Severity of Sleep-disordered Breathing
Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months
Measured: baseline and 1 year after treatment initiation
Change in General Health-related Quality of Life
Health Utilities Index - a 17-question general health related quality of life index. Total score indicates subjective assessment of HRQOL from close to death to perfect health Maximum = 1 Minimum = 0 Higher score means a better outcome
Measured: 3 months after treatment initiation
Change in General Health-related Quality of Life
Health Utilities Index - a 17-question general health related quality of life index. Total score indicates subjective assessment of HRQOL from close to death to perfect health Maximum = 1 Minimum = 0 Higher score means a better outcome
Measured: 1 year after treatment initiation
Quality Adjusted Life Years
Comparing quality adjusted life years for each arm (used to calculate the incremental cost effectiveness ratio). Quality adjusted life years were estimated using a utility score ranging from 0 (death) to 1.0 (perfect health) derived from the HUI3 questionnaire, combined with the total length of follow-up time for each patient at baseline 12 months
Measured: 1 year after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- The Lung Association
- Responsible party
- Principal investigator, Sachin R. Pendharkar, University of Calgary
- Investigators
- Sachin R Pendharkar, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191085
- Sponsor's protocol ID
- REB13-1280
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2014
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
PubMed 15781100Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.
PubMed 16282178Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
PubMed 10805822Flemons WW, Tsai W. Quality of life consequences of sleep-disordered breathing. J Allergy Clin Immunol. 1997 Feb;99(2):S750-6. doi: 10.1016/s0091-6749(97)70123-4.
PubMed 9042067Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220.
PubMed 14505600Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377.
PubMed 11502632Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.
PubMed 20339144Antic NA, Buchan C, Esterman A, Hensley M, Naughton MT, Rowland S, Williamson B, Windler S, Eckermann S, McEvoy RD. A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Mar 15;179(6):501-8. doi: 10.1164/rccm.200810-1558OC. Epub 2009 Jan 8.
PubMed 19136368J Santana M, Jaja O, Duan Q, D Penz E, L Fraser K, J Hanly P, R Pendharkar S. Comparison of patient-reported outcomes between alternative care provider-led and physician-led care for severe sleep disordered breathing: secondary analysis of a randomized clinical trial. J Patient Rep Outcomes. 2024 Sep 26;8(1):107. doi: 10.1186/s41687-024-00747-3.
PubMed 39325310Thornton CS, Tsai WH, Santana MJ, Penz ED, Flemons WW, Fraser KL, Hanly PJ, Pendharkar SR. Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e203088. doi: 10.1001/jamanetworkopen.2020.3088.
PubMed 32310283Pendharkar SR, Tsai WH, Penz ED, Santana MJ, Ip-Buting A, Kelly J, Flemons WW, Fraser KL, Hanly PJ. A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing. Ann Am Thorac Soc. 2019 Dec;16(12):1558-1566. doi: 10.1513/AnnalsATS.201901-087OC.
PubMed 31437008Ip-Buting A, Kelly J, Santana MJ, Penz ED, Flemons WW, Tsai WH, Fraser KL, Hanly PJ, Pendharkar SR. Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial. BMJ Open. 2017 Mar 29;7(3):e014012. doi: 10.1136/bmjopen-2016-014012.
PubMed 28360244
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
- ClinicalTrials.gov ID
- NCT02191085
- Acronym / sponsor ID
- REB13-1280
- Conditions
- Sleep Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- The Lung Association
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- to determine the effects of non-physician health care provider treatment to patient access;
- to determine health care utilization and related costs associated with non-physician health care provider treatment.
Detailed description
The difficulty in providing timely access to sleep specialists is widespread. These delays are particularly important for patients with severe sleep-disordered breathing (SDB) due to the increased risk of adverse clinical outcomes and potential associated healthcare costs. The lack of timely access has sparked an interest in the use of alternate care providers (ACPs) to manage patients with SDB. Our group and others have demonstrated that ACPs are an effective and efficient substitute for physicians for patients with uncomplicated SDB. However, the role of ACPs in the management of patients with severe SDB remains unclear.
Prompted by wait times that far exceed current Canadian guidelines, we have recently implemented an ACP-led "Fast Track" clinic for patients who are referred to the Foothills Medical Centre (FMC) Sleep Centre with suspected severe SDB. In this clinic, patients with suspected severe SDB are assessed by a sleep-trained registered respiratory therapist functioning as an ACP. Decisions regarding further sleep testing and treatment are made by the patient and ACP, under the guidance of a sleep physician. This model of care differs from a physician-led model that is used at the FMC Sleep Centre.
To evaluate this novel care delivery model, we have designed a randomized trial comparing outcomes for patients in the "Fast Track" clinic to those who undergo conventional, physician-led care. The specific goals of this study are:
- to compare the clinical effectiveness of an ACP-led clinic for patients with suspected severe SDB to physician-led management;
- to determine whether cycle times from referral to diagnosis and treatment for patients referred with suspected severe SDB can be reduced by an ACP-led clinic;
- to determine the impact of an ACP-led clinic on the demand for sleep physicians, ACPs and diagnostic testing;
- to compare the cost-effectiveness of these models of care using data on healthcare utilization, costs, and patient reported health-related quality of life (HRQOL).
Patients in the "Standard Management" arm will be assessed by a sleep respirologist and follow a management plan that is determined by the sleep physician and patient. This plan may involve polysomnography or the initiation of positive airway pressure (PAP) therapy. If further testing is ordered, follow-up may occur with the physician or with an ACP, at the physician's discretion. For patients initiating PAP therapy, the decision to delegate follow-up to an ACP will be left up to the physician, as the intent of this study is to observe real-world practice and not to change the management of individual patients.
In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. To ensure patient safety, the management plan will be discussed with a sleep respirologist, who will be designated as the patient's primary sleep physician. This sleep physician will be available at the FMC Sleep Centre during the "Fast Track" clinic to assist with the assessment of patients who appear unwell (e.g. severe hypoxemia, decompensated cardiorespiratory failure, etc.). As in the "Standard Management" arm, follow-up visits to review test results, discuss and initiate treatment, or to assess treatment response may occur with the ACP who performed the initial assessment or may be delegated to any other ACP.
As is usual procedure at the FMC Sleep Centre, ambulatory sleep test requisitions will be completed by ACPs or physicians, whereas all polysomnogram requisitions will be completed by the primary sleep physician to ensure adequate blinding of patient assignment. The research associate will ensure that all tests are interpreted in advance of clinic visits. Patients who are followed by ACPs in either arm can be referred to the primary sleep physician for assessment of non-respiratory sleep disorders, or for persistent symptoms such as daytime sleepiness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Management | No intervention | –Patients in the "Standard Management" arm will be assessed without any interventions.Patients will be assessed by a sleep respirologist and follow a management plan that is determined by the sleep physician and patient. This plan may involve polysomnography or the initiation of PAP therapy. If further testing is ordered, follow-up may occur with the physician or with an ACP, at the physician's discretion. For patients initiating PAP therapy, the decision to delegate follow-up to an ACP will be left up to the physician, as the intent of this study is to observe real-world practice and not to change the management of individual patients. |
| Fast Track | Active comparator | Procedure: Fast TrackIn the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- referred to the FMC Sleep Centre for assessment of SDB
- meet one of the three criteria for suspected severe SDB:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast TrackIn the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. To ensure patient safety, the management plan will be discussed with a sleep respirologist, who will be designated as the patient's primary sleep physician. This sleep physician will be available at the FMC Sleep Centre during the "Fast Track" clinic to assist with the assessment of patients who appear unwell. As in the "Standard Management" arm, follow-up visits to review test results, discuss and initiate treatment, or to assess treatment response may occur with the ACP who performed the initial assessment or may be delegated to any other ACP. | Procedure or surgery | Fast Track |
Primary outcome
Adherence to Positive Airway Pressure (PAP) Therapy
Time frame: 3 months after treatment initiation
Data includes number of hours used per night on all nights
16 secondary outcomes
Change in Daytime Sleepiness
Time frame: 3 months after treatment initiation
Health Care Utilization
Time frame: 1 year after treatment initiation
Total Healthcare Costs
Time frame: 1 year after treatment initiation
Time From Date of Referral to Date of Treatment Initiation
Time frame: Expected within 1 year (unknown due to nature of outcome)
Change in Daytime Sleepiness
Time frame: 1 year after treatment initiation
Adherence to Positive Airway Pressure (PAP) Therapy
Time frame: 1 year after treatment initiation
Change in Disease Specific Health-related Quality of Life
Time frame: 3 months after treatment initiation
Change in Disease Specific Health-related Quality of Life
Time frame: 1 year after treatment initiation
Patient Satisfaction
Time frame: 3 months after treatment initiation
Patient Satisfaction
Time frame: 1 year after treatment initiation
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits
Time frame: 1 year after treatment initiation
Change in Severity of Sleep-disordered Breathing
Time frame: baseline and 3 months after treatment initiation
Change in Severity of Sleep-disordered Breathing
Time frame: baseline and 1 year after treatment initiation
Change in General Health-related Quality of Life
Time frame: 3 months after treatment initiation
Change in General Health-related Quality of Life
Time frame: 1 year after treatment initiation
Quality Adjusted Life Years
Time frame: 1 year after treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15781100Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Background: PubMed 16282178Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.
- Background: PubMed 10805822Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
- Background: PubMed 9042067Flemons WW, Tsai W. Quality of life consequences of sleep-disordered breathing. J Allergy Clin Immunol. 1997 Feb;99(2):S750-6. doi: 10.1016/s0091-6749(97)70123-4.
- Background: PubMed 14505600Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220.
- Background: PubMed 11502632Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377.
- Background: PubMed 20339144Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.
- Background: PubMed 19136368Antic NA, Buchan C, Esterman A, Hensley M, Naughton MT, Rowland S, Williamson B, Windler S, Eckermann S, McEvoy RD. A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Mar 15;179(6):501-8. doi: 10.1164/rccm.200810-1558OC. Epub 2009 Jan 8.
- Derived from this study: PubMed 39325310J Santana M, Jaja O, Duan Q, D Penz E, L Fraser K, J Hanly P, R Pendharkar S. Comparison of patient-reported outcomes between alternative care provider-led and physician-led care for severe sleep disordered breathing: secondary analysis of a randomized clinical trial. J Patient Rep Outcomes. 2024 Sep 26;8(1):107. doi: 10.1186/s41687-024-00747-3.
- Derived from this study: PubMed 32310283Thornton CS, Tsai WH, Santana MJ, Penz ED, Flemons WW, Fraser KL, Hanly PJ, Pendharkar SR. Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e203088. doi: 10.1001/jamanetworkopen.2020.3088.
- Derived from this study: PubMed 31437008Pendharkar SR, Tsai WH, Penz ED, Santana MJ, Ip-Buting A, Kelly J, Flemons WW, Fraser KL, Hanly PJ. A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing. Ann Am Thorac Soc. 2019 Dec;16(12):1558-1566. doi: 10.1513/AnnalsATS.201901-087OC.
- Derived from this study: PubMed 28360244Ip-Buting A, Kelly J, Santana MJ, Penz ED, Flemons WW, Tsai WH, Fraser KL, Hanly PJ, Pendharkar SR. Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial. BMJ Open. 2017 Mar 29;7(3):e014012. doi: 10.1136/bmjopen-2016-014012.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sachin R Pendharkar, MD, MSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Track in people with Sleep Disordered Breathing, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Positive Airway Pressure (PAP) Therapy (time frame: 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02191085, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.