Study of the Sleepnet Elara APAP Device for Obstructive Sleep Apnea
This study is testing the Sleepnet Elara APAP device to see how well it works for people with obstructive sleep apnea (OSA). OSA is a condition where breathing repeatedly stops and starts during sleep. To join, you must be at least 18 years old, weigh 30kg (about 66 pounds) or more, and have been diagnosed with OSA (meaning you have more than 15 breathing interruptions per hour during sleep). The study will measure how much the Sleepnet Elara device reduces these breathing interruptions. The current recruitment status is unclear.
- Study design
- This is an open-label study, meaning both you and the study team will know you are receiving the Sleepnet Elara treatment. It plans to include 55 participants.
- What's involved
- You will sign a consent form, go through screening, and have one night of in-lab PSG (polysomnography), which is a sleep study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your breathing interruptions will be measured on Day 1 after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of the Sleepnet Elara APAP Device
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Anthony McLeod, MD · PRINCIPAL_INVESTIGATOR · University Sleep Disorders Center
Who to contact
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What this trial measures
- AHI 4%Day 1
The primary endpoint of this study is treatment night AHI 4%. A subject is considered a success if the Apnea Hypopnea Index calculated by using hypopneas that cause a 4% or greater drop in blood oxygen levels per hour of sleep (AHI4) measured during the 1-night treatment study (PSG) is less than 10 events/hour or less than 10% of the baseline AHI4 value determined at previous diagnosis, whichever is greater.