Clinical trial NCT04613414: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Access to Health Care
Time to Treatment
Treatment Adherence
Quality of Care
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Lung Association
First posted: 2020-11-03
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Positive airway pressure adherence
timeFrame: 3 months after treatment initiation
Secondary outcomes:
measure: Positive airway pressure therapy initiation
timeFrame: 1 week after sleep physician visit
measure: Adherent to positive airway pressure
timeFrame: 3 months after treatment initiation
measure: Sleepiness
timeFrame: 3 months after treatment initiation
measure: General health-related quality of life: Change in EuroQoL-5D-3L
timeFrame: 3 months after treatment initiation
measure: Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index
timeFrame: 3 months after treatment initiation
measure: Patient satisfaction: Visit-Specific Satisfaction Instrument total score
timeFrame: 3 months after treatment initiation
measure: Patient activation
timeFrame: 3 months after treatment initiation
measure: Patient activation level
timeFrame: 3 months after treatment initiation
measure: Self-efficacy: Self-Efficacy Measure for Sleep Apnea score
timeFrame: 3 months after treatment initiation
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre Sleep Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sachin Pendharkar
role: PRINCIPAL_INVESTIGATOR
References: