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Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613414
Recruitment Status : Active, not recruiting
First Posted : November 3, 2020
Last Update Posted : November 4, 2022
Sponsor:
Collaborator:
Canadian Lung Association
Information provided by (Responsible Party):
University of Calgary

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Early Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of an Early Management Strategy for Obstructive Sleep Apnea: A Randomized Trial
Actual Study Start Date : June 24, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Early Management
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
Other: Early Management
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

No Intervention: Usual Care
Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613414


Locations
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Canada, Alberta
Foothills Medical Centre Sleep Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Canadian Lung Association
Investigators
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Principal Investigator: Sachin Pendharkar University of Calgary
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT04613414    
Other Study ID Numbers: REB20-1667
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data may be shared upon completion of data sharing agreement
Time Frame: Data will be available 1 year after initial results are published.
Access Criteria: Please contact principal investigator with study proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Calgary:
Access to Health Care
Time to Treatment
Treatment Adherence
Quality of Care
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases