Obstructive Sleep ApneaNCT04613414
Evaluation of an Early Management Strategy for Obstructive Sleep Apnea
A study testing Early Management in people with Obstructive Sleep Apnea, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Early Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HSAT ODI >= events/hr and ESS 10 - 15 OR
- HSAT ODI 15 - 30 and ESS 15 or lower
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Early Management
- Keywords
- Access to Health Care, Time to Treatment, Treatment Adherence, Quality of Care
- Medical subject headings
- Sleep Apnea, Obstructive, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ManagementOther
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
| Study group | Role | What they receive |
|---|---|---|
| Early Management | Experimental | Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage Receives: Other: Early Management |
| Usual Care | No intervention | Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after treatment initiation
Secondary outcomes (9)
Positive airway pressure therapy initiation
Proportion of patients who initiate positive airway pressure therapy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start24 Jun 2022
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Lung Association
- Responsible party
- Sponsor
- Investigators
- Sachin Pendharkar, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613414
- Sponsor's protocol ID
- REB20-1667
- Status last verified
- Mar 2025
- First submitted
- 20 Oct 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data may be shared upon completion of data sharing agreement
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Early Management Strategy for Obstructive Sleep Apnea: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04613414
- Acronym / sponsor ID
- REB20-1667
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Access to Health Care, Time to Treatment, Treatment Adherence, Quality of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Lung Association
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Management | Experimental | Other: Early ManagementScheduled for sleep physician appointment within 1 month of home sleep apnea test/triage |
| Usual Care | No intervention | –Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HSAT ODI >= events/hr and ESS 10 - 15 OR
- HSAT ODI 15 - 30 and ESS 15 or lower
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early ManagementScheduled for sleep physician appointment within 1 month of home sleep apnea test/triage | Other | Early Management |
Primary outcome
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
9 secondary outcomes
Positive airway pressure therapy initiation
Time frame: 1 week after sleep physician visit
Adherent to positive airway pressure
Time frame: 3 months after treatment initiation
Sleepiness
Time frame: 3 months after treatment initiation
General health-related quality of life: Change in EuroQoL-5D-3L
Time frame: 3 months after treatment initiation
Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index
Time frame: 3 months after treatment initiation
Patient satisfaction: Visit-Specific Satisfaction Instrument total score
Time frame: 3 months after treatment initiation
Patient activation
Time frame: 3 months after treatment initiation
Patient activation level
Time frame: 3 months after treatment initiation
Self-efficacy: Self-Efficacy Measure for Sleep Apnea score
Time frame: 3 months after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified data may be shared upon completion of data sharing agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sachin Pendharkar principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Management in people with Obstructive Sleep Apnea, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive airway pressure adherence (time frame: 3 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.