Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

Evaluation of an Early Management Strategy for Obstructive Sleep Apnea: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Early Management

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre Sleep Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Management; Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage	Other: Early Management; Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
No Intervention: Usual Care; Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Lung Association
• Investigators: Principal Investigator: Sachin Pendharkar, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Treatment Adherence; Quality of Care; Time to Treatment; Access to Health Care
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Behavior; Health Behavior; Sleep Apnea, Obstructive; Treatment Adherence and Compliance
• Other Study ID Numbers: REB20-1667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data may be shared upon completion of data sharing agreement
• IPD Sharing Time Frame: Data will be available 1 year after initial results are published.
• IPD Sharing Access Criteria: Please contact principal investigator with study proposal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No