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Completed NCT07559708

A Study of the Sleepnet Elara APAP Device

Conditions: Sleep Apnea - Obstructive

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 89
Sponsor: Sleepnet Corporation

Location: University Sleep Disorders Center Auburn Alabama

Summary

The goal of this study is to evaluate the effectiveness of the Elara APAP device.

Eligibility Criteria

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 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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07559708). StuddyBuddy aggregates publicly available trial information.