A Study of the Sleepnet Elara APAP Device

Exclusion Criteria

• •1. Body weight \< 30kg
• •2. Female currently bearing a child or intending to become pregnant prior to the sleep study.
• •3. Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study
• •4. Has pneumothorax, pneumomediastinum
• •5. Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus
• •6. Ongoing shock from various causes untreated
• •7. Current epistaxis
• •8. Non-compliant with APAP usage (\< 4 hours per night on 70% of nights)
• •9. Upper gastrointestinal bleeding that has not been effectively controlled
• •10. Has obstructive vocal cord polyps
• •11. Severe coronary heart disease with left heart failure
• •12. Acute otitis media inflammation (must be resolved prior to sleep study)
• •13. Excessive respiratory secretions and cough weakness
• •14. Weak spontaneous breathing
• •15. Tracheal intubation (nasal or oral) and tracheotomy
• •16. Severe nasal congestion from various causes
• •17. Lung bullae
• •18. Central sleep apnea index \>5 events/hr
• •19. 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).