Trial Outcomes & Findings for Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing (NCT NCT02191085)

NCT ID: NCT02191085

Last Updated: 2025-07-22

Results Overview

Data includes number of hours used per night on all nights

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 186 participants
• Primary outcome timeframe: 3 months after treatment initiation
• Results posted on: 2025-07-22

Participant Flow

Participant milestones

Measure	Standard Management 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 In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Overall Study STARTED	92	94
Overall Study Included in Modified Intention to Treat Population	75	81
Overall Study COMPLETED	75	81
Overall Study NOT COMPLETED	17	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reported number reflects those that received intervention as per modified intention to treat design

Baseline characteristics by cohort

Measure	Standard Management n=92 Participants 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 n=94 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.	Total n=186 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 13 • n=75 Participants • Reported number reflects those that received intervention as per modified intention to treat design	54 years STANDARD_DEVIATION 12 • n=81 Participants • Reported number reflects those that received intervention as per modified intention to treat design	55 years STANDARD_DEVIATION 12 • n=156 Participants • Reported number reflects those that received intervention as per modified intention to treat design
Sex: Female, Male Female	21 Participants n=75 Participants • Reported number reflects those that received intervention as per modified intention to treat design	23 Participants n=81 Participants • Reported number reflects those that received intervention as per modified intention to treat design	44 Participants n=156 Participants • Reported number reflects those that received intervention as per modified intention to treat design
Sex: Female, Male Male	54 Participants n=75 Participants • Reported number reflects those that received intervention as per modified intention to treat design	58 Participants n=81 Participants • Reported number reflects those that received intervention as per modified intention to treat design	112 Participants n=156 Participants • Reported number reflects those that received intervention as per modified intention to treat design
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	92 participants n=92 Participants	94 participants n=94 Participants	186 participants n=186 Participants
Body mass index, kg/m^2	39 kg/m^2 STANDARD_DEVIATION 9 • n=75 Participants • Reported number reflects those that received intervention as per modified intention to treat design	40 kg/m^2 STANDARD_DEVIATION 10 • n=81 Participants • Reported number reflects those that received intervention as per modified intention to treat design	39 kg/m^2 STANDARD_DEVIATION 10 • n=156 Participants • Reported number reflects those that received intervention as per modified intention to treat design
Respiratory Event Index, events/h	55 events/h STANDARD_DEVIATION 29 • n=75 Participants • Reported number reflects those that received intervention as per modified intention to treat design	51 events/h STANDARD_DEVIATION 28 • n=81 Participants • Reported number reflects those that received intervention as per modified intention to treat design	53 events/h STANDARD_DEVIATION 28 • n=156 Participants • Reported number reflects those that received intervention as per modified intention to treat design
Mean oxygen saturation on home sleep apnea test	86 % oxygen saturation STANDARD_DEVIATION 5 • n=75 Participants • Reported number reflects those that received intervention as per modified intention to treat design	85 % oxygen saturation STANDARD_DEVIATION 5 • n=81 Participants • Reported number reflects those that received intervention as per modified intention to treat design	85 % oxygen saturation STANDARD_DEVIATION 5 • n=156 Participants • Reported number reflects those that received intervention as per modified intention to treat design
Apnea hypopnea index, events/h	77 events/h STANDARD_DEVIATION 50 • n=46 Participants • Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography	75 events/h STANDARD_DEVIATION 59 • n=40 Participants • Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography	76 events/h STANDARD_DEVIATION 54 • n=86 Participants • Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography
Mean oxygen saturation on polysomnography	86 % oxygen saturation STANDARD_DEVIATION 5 • n=46 Participants • Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography	85 % oxygen saturation STANDARD_DEVIATION 5 • n=40 Participants • Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography	85 % oxygen saturation STANDARD_DEVIATION 5 • n=86 Participants • Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography

PRIMARY outcome

Timeframe: 3 months after treatment initiation

Data includes number of hours used per night on all nights

Outcome measures

Measure	Standard Management n=75 Participants 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 n=81 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Adherence to Positive Airway Pressure (PAP) Therapy	4 hours per night Interval 3.3 to 4.7	3.5 hours per night Interval 2.8 to 4.2

SECONDARY outcome

Timeframe: 3 months after treatment initiation

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

Outcome measures

Measure	Standard Management n=60 Participants 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 n=67 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in Daytime Sleepiness	3.4 score on a scale Interval 1.8 to 5.0	5.4 score on a scale Interval 4.3 to 6.8

SECONDARY outcome

Timeframe: 1 year after treatment initiation

Costs for physician visits, emergency department visits, hospitalizations

Outcome measures

Measure	Standard Management n=75 Participants 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 n=81 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Health Care Utilization Physician costs	1960 dollars Standard Deviation 2440	1670 dollars Standard Deviation 2430
Health Care Utilization Emergency Department visits	282 dollars Standard Deviation 831	219 dollars Standard Deviation 585
Health Care Utilization Hospitalization visits	1410 dollars Standard Deviation 4410	1760 dollars Standard Deviation 5930

SECONDARY outcome

Timeframe: 1 year after treatment initiation

Comparing costs for each arm (used to calculate the incremental cost effectiveness ratio)

Outcome measures

Measure	Standard Management n=75 Participants 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 n=80 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Total Healthcare Costs	8572 dollars Standard Deviation 7617	8203 dollars Standard Deviation 8841

SECONDARY outcome

Timeframe: Expected within 1 year (unknown due to nature of outcome)

Comparing cycle times for intervention vs. control arm

Outcome measures

Measure	Standard Management n=75 Participants 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 n=81 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Time From Date of Referral to Date of Treatment Initiation	134 days Interval 121.0 to 147.0	110 days Interval 94.0 to 125.0

SECONDARY outcome

Timeframe: 1 year after treatment initiation

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

Outcome measures

Measure	Standard Management n=37 Participants 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 n=44 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in Daytime Sleepiness	4.62 units on a scale Interval 2.37 to 6.88	1.79 units on a scale Interval 0.97 to 4.55

SECONDARY outcome

Timeframe: 1 year after treatment initiation

Data includes number of hours used per night.

Outcome measures

Measure	Standard Management n=37 Participants 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 n=38 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Adherence to Positive Airway Pressure (PAP) Therapy	5.56 hours/night Interval 4.76 to 6.35	6.14 hours/night Interval 5.44 to 6.85

SECONDARY outcome

Timeframe: 3 months after treatment initiation

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

Outcome measures

Measure	Standard Management n=60 Participants 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 n=66 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in Disease Specific Health-related Quality of Life	0.83 units on a scale Interval 0.5 to 1.2	1.2 units on a scale Interval 0.9 to 1.5

SECONDARY outcome

Timeframe: 1 year after treatment initiation

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

Outcome measures

Measure	Standard Management n=37 Participants 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 n=44 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in Disease Specific Health-related Quality of Life	0.99 units on a scale Interval 0.45 to 1.53	1.39 units on a scale Interval 1.0 to 1.78

SECONDARY outcome

Timeframe: 3 months after treatment initiation

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.

Outcome measures

Measure	Standard Management n=50 Participants 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 n=56 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Patient Satisfaction	36 units on a scale Interval 34.0 to 38.0	38 units on a scale Interval 36.0 to 39.0

SECONDARY outcome

Timeframe: 1 year after treatment initiation

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.

Outcome measures

Measure	Standard Management n=35 Participants 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 n=44 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Patient Satisfaction	34.54 units on a scale Interval 31.74 to 37.34	37.39 units on a scale Interval 35.54 to 39.23

SECONDARY outcome

Timeframe: 1 year after treatment initiation

Reported as costs for home sleep apnea tests, polysomnograms, new and follow-up clinical visits

Outcome measures

Measure	Standard Management n=75 Participants 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 n=81 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits Home sleep apnea test costs	57.2 dollars Standard Deviation 21.4	56.2 dollars Standard Deviation 20.3
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits Polysomnogram costs	649 dollars Standard Deviation 589	566 dollars Standard Deviation 637
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits New clinical visit costs	182 dollars Standard Deviation 0	56.2 dollars Standard Deviation 0
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits Follow-up clinical visits	101 dollars Standard Deviation 119	77.6 dollars Standard Deviation 91.3

SECONDARY outcome

Timeframe: baseline and 3 months after treatment initiation

Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months

Outcome measures

Measure	Standard Management n=55 Participants 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 n=61 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in Severity of Sleep-disordered Breathing	-45 events/h Interval -53.0 to -38.0	-41 events/h Interval -48.0 to -34.0

SECONDARY outcome

Timeframe: baseline and 1 year after treatment initiation

Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months

Outcome measures

Measure	Standard Management n=33 Participants 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 n=32 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in Severity of Sleep-disordered Breathing	-46 events/h Interval -58.0 to -33.0	-44 events/h Interval -56.0 to -32.0

SECONDARY outcome

Timeframe: 3 months after treatment initiation

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

Outcome measures

Measure	Standard Management n=60 Participants 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 n=66 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in General Health-related Quality of Life	0.06 units on a scale Interval -0.01 to 0.14	0.15 units on a scale Interval 0.08 to 0.21

SECONDARY outcome

Timeframe: 1 year after treatment initiation

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

Outcome measures

Measure	Standard Management n=37 Participants 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 n=44 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Change in General Health-related Quality of Life	0.15 units on a scale Interval 0.05 to 0.24	0.15 units on a scale Interval 0.06 to 0.23

SECONDARY outcome

Timeframe: 1 year after treatment initiation

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

Outcome measures

Measure	Standard Management n=75 Participants 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 n=80 Participants In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. Fast Track: 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.
Quality Adjusted Life Years	0.587 quality adjusted life years Standard Deviation 0.306	0.654 quality adjusted life years Standard Deviation 0.289

Adverse Events

Standard Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fast Track

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sachin Pendharkar

University of Calgary

Phone: 403-210-8617

Email: sachin.pendharkar@ucalgary.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place