Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

Not Applicable

Active, not recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Early Management

• Registration Number: NCT04613414
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2022-06-24
• Status Verified: 2023-12
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2024-12-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Management	Early Management	Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Primary Outcome Measures

Name	Time	Method
Positive airway pressure adherence	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

Name	Time	Method
Self-efficacy: Self-Efficacy Measure for Sleep Apnea score	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
Adherent to positive airway pressure	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
General health-related quality of life: Change in EuroQoL-5D-3L	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
Patient satisfaction: Visit-Specific Satisfaction Instrument total score	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
Positive airway pressure therapy initiation	1 week after sleep physician visit	Proportion of patients who initiate positive airway pressure therapy
Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index	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
Sleepiness	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
Patient activation level	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
Patient activation	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

Trial Locations

Locations (1)

Foothills Medical Centre Sleep Centre; 🇨🇦 Calgary, Alberta, Canada