A Prospective, Open-label Study to Assess the Efficacy of the Elara APAP Device When Used in Patients With Obstructive Sleep Apnea
Sleepnet Corporation
Summary
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
Description
A prospective open label study to assess the efficacy of the Elara APAP device when used in patients with obstructive sleep apnea. Subjects will sign Informed Consent and undergo screening/baseline and a 1 night in-lab PSG.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Body weight ≥ 30kg 2. Willing and able to consent, adhere to study requirements and receive mask treatment 3. ≥ 18 years of age 4. 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) 5. Currently utilizing an APAP Device for ongoing treatment of OSA Exclusion Criteria: 1. Body weight \< 30kg 2. Female currently bearing a child or intendin…
Interventions
- DeviceSleepnet Elara Treatment
Subject to have a 1 night in-lab PSG
Location
- University Sleep Disorders CenterAuburn, Alabama