Neurostimulation for Sleep Disordered Breathing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLunair Medical
About this trial
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 judgment 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
Design model
Single group
Treatments tested in this trial
Neuro stimulator Implant
DeviceNeuro Stimulator for treating sleep disordered breathing
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Alpha Lunair System implanted subjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety Endpoint - assessment of procedure or device related adverse events
Incidence of adverse events (AEs) related to the Lunair system or procedure
Time frame
enrollment to 12 months post-implantSecondary outcomes
1
Improvement in sleep disordered breathing per sleep study
Improvement in sleep disordered breathing at 6, 12 and 24 months post implant during an attended sleep study
Time frame
six months, 12 month and 24 months post implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov