Assessment of OSA in Latin American and Response to Neuromod Therapy
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLunair Medical
About this trial
The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate/severe obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.
Eligibility criteria
Qualifiers
Subject is aged ≥ 18 years old
Subject is willing and able to provide informed consent
Subject is geographically stable
Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and/or behavioral treatments)
Disqualifiers
Subject is currently implanted with another active implantable device.
Subject is actively enrolled in another premarket investigational study (medical device or drug) unless approved by Sponsor in writing.
Subject is considered vulnerable such as incarcerated or cognitively impaired.
Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that in the opinion of the investigator may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
Trial design
Treatments tested in this trial
- Drug Induced Sleep Endoscopy with PNS
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov