Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluation of an Early Management Strategy for Obstructive Sleep Apnea: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613414
• Other study ID #: REB20-1667
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: December 2023
• Source: University of Calgary
• Contact: Sachin Pendharkar
• Phone: 4032103904
• Email: sachin.pendharkar[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Early Management
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Locations

Country	Name	City	State
Canada	Foothills Medical Centre Sleep Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after treatment initiation
Secondary	Positive airway pressure therapy initiation	Proportion of patients who initiate positive airway pressure therapy	1 week after sleep physician visit
Secondary	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	3 months after treatment initiation
Secondary	Sleepiness	Change in Epworth Sleepiness Scale score from baseline to three months. Scale is from 0-24 with higher scores indicating greater sleepiness	3 months after treatment initiation
Secondary	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	3 months after treatment initiation
Secondary	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	3 months after treatment initiation
Secondary	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	3 months after treatment initiation
Secondary	Patient activation	Change in Patient Activation Measure score from baseline to three months. Scale is from 0-100 with higher scores indicating greater activation	3 months after treatment initiation
Secondary	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	3 months after treatment initiation
Secondary	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	3 months after treatment initiation