Neurostimulation for Sleep Disordered Breathing (SDB)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLunair Medical
About this trial
This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
Eligibility criteria
Qualifiers
Subject does not tolerate, not compliant to, or have access to alternative Sleep Disordered Breathing treatments
Subject has moderate to severe sleep disordered breathing as diagnosed by PSG
Disqualifiers
Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
Any reason for which, in the judgement of the investigator, the subject is considered to be a poor study candidate
Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.
Subject has a need for chronic supplemental oxygen therapy for any reason
Trial design
Treatments tested in this trial
- Neuro stimulator implant
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov