CClinicalTrials.gg
CompletedNCT04613414Updated May 4, 2026

Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

An interventional study of Early Management in Obstructive Sleep Apnea, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Calgary · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Access to Health Care
  • Time to Treatment
  • Treatment Adherence
  • Quality of Care
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In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 468 are open to participants now.

This study's enrollment of 103 is above the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Early Management

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

    Other: Early Management

  • No intervention
    Usual Care

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

Interventions

  • OtherEarly Management

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

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What researchers measure

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

    Time frame: 3 months after treatment initiation

Secondary outcomes

  1. Positive airway pressure therapy initiation

    Proportion of patients who initiate positive airway pressure therapy

    Time frame: 1 week after sleep physician visit

  2. 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

    Time frame: 3 months after treatment initiation

  3. Sleepiness

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

    Time frame: 3 months after treatment initiation

  4. 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

    Time frame: 3 months after treatment initiation

  5. 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

    Time frame: 3 months after treatment initiation

  6. 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

    Time frame: 3 months after treatment initiation

  7. Patient activation

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

    Time frame: 3 months after treatment initiation

  8. 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

    Time frame: 3 months after treatment initiation

  9. 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

    Time frame: 3 months after treatment initiation

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Study locations

1 site
  • Foothills Medical Centre Sleep Centre
    Calgary, Alberta T2N 2T9, Canada
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References and documents

Individual participant data

Plan to share: Yes — Deidentified data may be shared upon completion of data sharing agreement

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04613414
Lead sponsor
University of Calgary
Collaborators
Canadian Lung Association
Responsible party
Sponsor
First posted
Nov 3, 2020
Start date
Jun 24, 2022
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025
Last update
May 4, 2026

Study contacts

Sachin Pendharkar
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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