Actively Recruiting
Assessment of Obstructive Sleep Apnea in Latin American Adults and Response to Neuromodulation Therapy
Led by Lunair Medical · Updated on 2025-09-03
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Latin American adults diagnosed with moderate to severe obstructive sleep apnea (OSA) to better understand the characteristics of their upper airway and how they respond to a neuromodulation therapy. This early phase 1 study aims to compare responses in this population to previous studies conducted in the U.S., focusing on detailed airway assessments to evaluate the therapy's potential. Participants will undergo an overnight sleep study (polysomnography) followed by a drug-induced sleep endoscopy (DISE) procedure with phrenic nerve stimulation (PNS) during a 30-minute research period. The study uses VOTE scoring to classify the type of upper airway collapse and to assess how the neuromodulation treatment affects airway opening and its connection to patient characteristics. During the study, participants will be evaluated from enrollment to study exit, usually within three weeks of screening. Researchers will review sleep study data, airway collapse patterns, and response to nerve stimulation. The main outcome measures include response differences compared to U.S. data, airway collapse characterization via VOTE scoring, and the effect of phrenic nerve stimulation on OSA. Safety and treatment viability are monitored throughout the study period.
CONDITIONS
Brief 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 therapies
- Subject has an Apnea-Hypopnea Index (AHI) score between 15 and less than 100 events per hour based on in-lab polysomnography studies
You will not qualify if you...
- Subject currently has another active implantable device
- Subject is enrolled in another investigational study unless approved by the sponsor
- Subject is considered vulnerable, such as incarcerated or cognitively impaired
- Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness or sleep patterns
- Subject has uncontrolled neurological, medical, social, or psychological problems that may complicate study procedures
- Subject had upper respiratory tract surgery within 60 days prior to screening
- Subject requires chronic supplemental oxygen therapy or has low oxygen levels
- Subject has other sleep disorders or behaviors that affect sleep assessments unrelated to OSA
- 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 sleep study
- Subject has a BMI greater than 40 kg/m2
- Subject has an active systemic infection
- Subject is pregnant or plans pregnancy during the study period
- Subject has large tonsils (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 jaw abnormalities or craniofacial syndromes
- Subject had prior surgery or radiation for cancer or malformations in the throat area
- Subject has significant oxygen desaturation or high central apnea event proportion on sleep study
- Subject has low sleep efficiency below 80%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 weeks after screening
Participants undergo an overnight polysomnography (sleep study) followed by a Drug Induced Sleep Endoscopy (DISE) procedure with a 30-minute research period to assess upper airway collapse and response to phrenic nerve stimulation.
1 overnight sleep study visit and 1 DISE procedure visit
Trial Site Locations
Total: 1 location
1
Sanatorio Americano
Asunción, Paraguay
Actively Recruiting
Research Team
A
Andrea Director of Clinical Operations
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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