Actively Recruiting
Assessment of OSA in Latin American and Response to Neuromod Therapy
Led by Lunair Medical · Updated on 2025-09-03
50
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of OSA in Latin American and Response to Neuromod Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is aged 18 years or older
- Subject is willing and able to provide informed consent
- Subject is geographically stable
- Subject does not have access to alternative sleep disordered breathing treatments such as oral appliances or behavioral treatments
- Subject has an Apnea-Hypopnea Index (AHI) score between 15 and less than 100 events per hour on screening polysomnography (PSG) under AASM 4% criteria
You will not qualify if you...
- Subject currently has an active implantable device
- Subject is enrolled in another premarket investigational study unless approved by Sponsor in writing
- Subject is considered vulnerable (incarcerated or cognitively impaired)
- Subject takes opioids, narcotics, sleep or psychotic medications or supplements that may affect consciousness, breathing, sleep, or alertness
- Subject has uncontrolled neurological, medical, social, or psychological problems complicating study procedures (e.g., uncontrolled hypertension, unstable angina, heart failure, COPD, major depression, Parkinson's, epilepsy)
- Subject had upper respiratory tract surgery within 60 days prior to screening PSG
- Subject requires chronic supplemental oxygen therapy or has PaO2 less than 70 mm Hg
- Subject has other sleep disorders or behaviors confounding sleepiness or PSG outcomes (e.g., narcolepsy with cataplexy, idiopathic hypersomnolence, insomnia, REM sleep behavior disorder, restless leg syndrome, periodic limb movement)
- Subject has severe chronic kidney disease (GFR less than 30)
- Subject has excessive use of alcohol, tobacco, caffeine, or recreational drugs
- Subject is unwilling or unable to avoid alcohol for 24 hours before each PSG study
- Subject has a BMI over 40 kg/m2
- Subject has an active systemic infection
- Female subjects who are pregnant or planning pregnancy during the study without a negative pregnancy test within 14 days prior to enrollment
- Subject has tonsil size 3 or 4
- Subject has history of phrenic nerve palsy or diaphragm asymmetry
- Subject has upper airway trauma affecting tongue movement or function
- Subject has severe mandibular deficiency, retrognathia, or craniofacial syndromes
- Subject had prior surgical resection or radiation for cancer or malformations in the larynx, tongue, or throat
- Subject has oxygen saturation drop over 10% with falls index over 15 events per hour on PSG
- Subject has more than 25% central apnea events on PSG (up to 3 patients allowed with CAI+MAI 25% or higher)
- Subject has sleep efficiency below 80%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sanatorio Americano
Asunción, Paraguay
Actively Recruiting
Research Team
A
Andrea Director of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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