Expiratory Pressure Relief for Sleep Apnea

N/A

Waitlist Available

Research Sponsored by SleepRes Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up averaged over every night for each 4-night arm

Summary

This trial is studying the effects of a pressure relief algorithm (PRA) on APAP therapy in participants with Obstructive Sleep Apnea (OSA). Participants who use an APAP device with

Who is the study for?

This trial is for people who regularly use a PAP device more than four hours each night to manage obstructive sleep apnea and have certain pressure settings on their device. It's not for those who drink heavily, use illegal drugs, or have conditions that could make the study risky or affect its results.

What is being tested?

The study tests if turning on an Expiratory Pressure Relief (PRA) feature affects therapy pressure in patients using auto-adjusting positive airway pressure (APAP) devices. Participants will alternate between having PRA on and off over eight nights to see how it impacts their treatment.

What are the potential side effects?

Since this trial involves adjusting settings on a medical device rather than testing a new medication, traditional side effects are not expected. However, changes in airway pressure may affect comfort during sleep.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ averaged over every night for each 4-night arm

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~averaged over every night for each 4-night arm

This trial's timeline: 3 weeks for screening, Varies for treatment, and averaged over every night for each 4-night arm for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

P95/P90

Secondary study objectives

AHI

Leak

Usage

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: APAP w/ EPR OnExperimental Treatment1 Intervention

The patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR on if they do not already use it that way.

Group II: APAP w/ EPR OffPlacebo Group1 Intervention

The patient will use their normal CPAP device and equipment in the normal operating mode but we will set EPR off if they do not already use it that way.

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