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NCT Number: NCT04613414

Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Dyssomnias Health Behavior Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre Sleep Centre

Calgary, Alberta, T2N 2T9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Early Management

Other

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

Primary outcomes

  1. Positive airway pressure adherence

    Time frame: 3 months after treatment initiation

    Mean number of hours of positive airway pressure use per night in the four weeks prior to three month follow-up

Secondary outcomes

  1. Positive airway pressure therapy initiation

    Time frame: 1 week after sleep physician visit

    Proportion of patients who initiate positive airway pressure therapy

  2. Adherent to positive airway pressure

    Time frame: 3 months after treatment initiation

    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. Sleepiness

    Time frame: 3 months after treatment initiation

    Change in Epworth Sleepiness Scale score from baseline to three months. Scale is from 0-24 with higher scores indicating greater sleepiness

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

    Time frame: 3 months after treatment initiation

    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

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

    Time frame: 3 months after treatment initiation

    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

  6. Patient satisfaction: Visit-Specific Satisfaction Instrument total score

    Time frame: 3 months after treatment initiation

    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

  7. Patient activation

    Time frame: 3 months after treatment initiation

    Change in Patient Activation Measure score from baseline to three months. Scale is from 0-100 with higher scores indicating greater activation

  8. Patient activation level

    Time frame: 3 months after treatment initiation

    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

  9. Self-efficacy: Self-Efficacy Measure for Sleep Apnea score

    Time frame: 3 months after treatment initiation

    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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Lung Association

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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