Early Management Strategy for Obstructive Sleep Apnea

Recruiting in Palo Alto (17 mi)

Overseen bySachin Pendharkar

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for individuals with obstructive sleep apnea who have moderate sleepiness and haven't been hospitalized recently for unstable heart/lung conditions, don't have upcoming major surgery, no recent car accidents, not on multiple blood pressure meds, not in a safety-critical job, without other severe sleep issues or extreme daytime sleepiness, and no prior OSA treatment.

Inclusion Criteria

Your sleep test result shows that you have moderate sleep apnea and you experience mild to moderate daytime sleepiness.

You have a high number of breathing events while sleeping and you score between 10 and 15 on the Epworth Sleepiness Scale.

Exclusion Criteria

I have been treated for sleep apnea before.

I was hospitalized for heart or lung problems in the last 30 days.

You were in a car accident within the past year.

+6 more

Participant Groups

The study tests if getting care quickly after an obstructive sleep apnea diagnosis improves sticking to positive airway pressure therapy at three months. It also looks at whether this early management betters patient's reported sleepiness, quality of life and satisfaction compared to usual care.

2Treatment groups

Experimental Treatment

Active Control

Group I: Early ManagementExperimental Treatment1 Intervention

Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Group II: Usual CareActive Control1 Intervention

Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage