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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Drug Induced Sleep Endoscopy with PNS
Diagnostic testEnrolled subjects will complete an overnight PSG and then undergo a DISE procedure with a 30-minute research period.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Trans-Q DISE treated subjectsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Understand the difference in response compared to prior U.S. based studies to the response in Latin America.
Reviewing phrenic nerve stimulation response to literature of US based population
Time frame
enrollment to study exit, usually within 3 weeks of screening2
Use VOTE scoring to characterize the type of upper airway collapse as assessed via DISE.
Upper Airway will be characterized using VOTE scoring as assessed by a qualified, trained Independent Reviewer.
Time frame
enrollment to study exit, usually within 3 weeks of screening3
Use VOTE scoring and airway opening measurements to characterize the effect of Phrenic Nerve Stimulation and if it is a viable and effective treatment of OSA and correlation to phenotype.
In combination with VOTE scoring and airway opening measurements, the effects of phrenic nerve stimulation will be compared across treated patient population.
Time frame
enrollment to study exit, usually within 3 weeks of screeningSponsors and contacts
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Source ClinicalTrials.gov