Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

NCT04613414 | Completed

• 1 other identifier: REB20-1667
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Access to Health Care; Time to Treatment; Treatment Adherence; Quality of Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Positive airway pressure therapy initiation

  1 week after sleep physician visit

• Adherent to positive airway pressure

  3 months after treatment initiation

• Sleepiness

  3 months after treatment initiation

• General health-related quality of life: Change in EuroQoL-5D-3L

  3 months after treatment initiation

• Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index

  3 months after treatment initiation

Study Arms (2)

Early Management

EXPERIMENTAL

Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Other: Early Management

Usual Care

NO INTERVENTION

Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage

Interventions

Early Management OTHER

Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Early Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HSAT ODI \>= events/hr and ESS 10 - 15 OR
• HSAT ODI 15 - 30 and ESS 15 or lower

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Lung Association: collaborator

Study Sites (1)

Foothills Medical Centre Sleep Centre

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Health Behavior; Behavior

Study Officials

• Sachin Pendharkar

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 3, 2020
• Study Start: June 24, 2022
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 4, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available 1 year after initial results are published.
• Access Criteria: Please contact principal investigator with study proposal

Locations

CA (1)