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NCT05608486
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
Conditions: Obstructive Sleep Apnea, Sleep Apnea
Sex: All
Ages: 18 Years – N/A
Sponsor: Sommetrics, Inc.
Summary
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
Eligibility Criteria
Inclusion Criteria:The subject completed study SOM-029 (SUPRA).The Investigator feels that the subject experienced sufficient benefit from aerSleep II to justify its further use.In the Investigator's judgement, the subject will be able to understand and comply with all study procedures.Exclusion Criteria:The Investigator feels that, for any reason, the subject's participation may not be in his or her best interest.Any condition or circumstance that in the opinion of the Investigator is likely to prevent accurate data collection or bias the results.The subject is pregnant or plans to become pregnant during the course of the study.
Source: ClinicalTrials.gov (NCT05608486). StuddyBuddy aggregates publicly available trial information.