A Study of the Sleepnet Elara APAP Device (NCT07559708) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study of the Sleepnet Elara APAP Device
United States55 participantsStarted 2026-04-27
Plain-language summary
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Body weight ≥ 30kg
✓. Willing and able to consent, adhere to study requirements and receive mask treatment
✓. ≥ 18 years of age
✓. Diagnosed with OSA (Total AHI \>15 events/hr) by a practicing physician within the last 6 months. A re-diagnosis may be necessary to establish current baseline AHI in case there has been significant weight change or other co-morbidities since the previous diagnosis (per PI discretion)
✓. Currently utilizing an APAP Device for ongoing treatment of OSA
Exclusion criteria
✕. Body weight \< 30kg
✕. Female currently bearing a child or intending to become pregnant prior to the sleep study.
✕. Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study
✕. Has pneumothorax, pneumomediastinum
✕. Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus
✕. Ongoing shock from various causes untreated
✕. Current epistaxis
✕. Non-compliant with APAP usage (\< 4 hours per night on 70% of nights)