A Study of the Sleepnet Elara APAP Device

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.

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)
• Upper gastrointestinal bleeding that has not been effectively controlled
• Has obstructive vocal cord polyps
• Severe coronary heart disease with left heart failure
• Acute otitis media inflammation (must be resolved prior to sleep study)
• Excessive respiratory secretions and cough weakness
• Weak spontaneous breathing
• Tracheal intubation (nasal or oral) and tracheotomy
• Severe nasal congestion from various causes
• Lung bullae
• Central sleep apnea index >5 events/hr
• Have another significant sleep disorder(s) that in the opinion of the investigator would confound the results of the study (e.g. periodic leg movements >15/hr or insomnia that would interfere with completing the sleep study).