Back to resultsEvaluation of an Early Management Strategy for Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Early Management
Sponsored by
About this trial
This is an interventional health services research trial for Obstructive Sleep Apnea focused on measuring Access to Health Care, Time to Treatment, Treatment Adherence, Quality of Care
Eligibility Criteria
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)
Sites / Locations
- Foothills Medical Centre Sleep Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early Management
Usual Care
Arm Description
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Positive airway pressure therapy initiation
Proportion of patients who initiate positive airway pressure therapy
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
Sleepiness
Change in Epworth Sleepiness Scale score from baseline to three months. Scale is from 0-24 with higher scores indicating greater sleepiness
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
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
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
Patient activation
Change in Patient Activation Measure score from baseline to three months. Scale is from 0-100 with higher scores indicating greater activation
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
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
Full Information
NCT ID
NCT04613414
First Posted
October 20, 2020
Last Updated
November 2, 2022
Sponsor
University of Calgary
Collaborators
Canadian Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT04613414
Brief Title
Evaluation of an Early Management Strategy for Obstructive Sleep Apnea
Official Title
Evaluation of an Early Management Strategy for Obstructive Sleep Apnea: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Canadian Lung Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Access to Health Care, Time to Treatment, Treatment Adherence, Quality of Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Management
Arm Type
Experimental
Arm Description
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage
Intervention Type
Other
Intervention Name(s)
Early Management
Intervention Description
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
Primary Outcome Measure Information:
Title
Positive airway pressure adherence
Description
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 Outcome Measure Information:
Title
Positive airway pressure therapy initiation
Description
Proportion of patients who initiate positive airway pressure therapy
Time Frame
1 week after sleep physician visit
Title
Adherent to positive airway pressure
Description
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
Title
Sleepiness
Description
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
Title
General health-related quality of life: Change in EuroQoL-5D-3L
Description
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
Title
Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index
Description
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
Title
Patient satisfaction: Visit-Specific Satisfaction Instrument total score
Description
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
Title
Patient activation
Description
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
Title
Patient activation level
Description
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
Title
Self-efficacy: Self-Efficacy Measure for Sleep Apnea score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sachin Pendharkar
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre Sleep Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Evaluation of an Early Management Strategy for Obstructive Sleep Apnea
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