Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

N/AActive Not RecruitingNCT04613414

University of Calgary170 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

170

Conditions

Obstructive Sleep Apnea

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: 3 months after treatment initiation

Secondary Outcomes

Positive airway pressure therapy initiation

Proportion of patients who initiate positive airway pressure therapy

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 months after treatment initiation

Evaluation of an Early Management Strategy for Obstructive Sleep Apnea

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes