What is this study trying to find out about obstructive sleep apnea?

This study is evaluating the upper airway characteristics and the response to a neuromodulation therapy in Latin American adults with moderate to severe obstructive sleep apnea. Researchers want to understand how this therapy works in this population compared to prior U.S.-based studies. The study is sponsored by Lunair Medical and aims to improve knowledge of treatment responses.

Who may be eligible for this obstructive sleep apnea clinical trial?

Adults aged 18 years and older with moderate to severe obstructive sleep apnea may be eligible. Both men and women can participate. Important factors include not having other implantable devices, not using certain medications that affect sleep, and not being pregnant. Please review eligibility criteria for more details.

Is there any cost to participate in this obstructive sleep apnea clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside the study-related care.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

ID06762873

Study of Obstructive Sleep Apnea in Latin American Adults and Their Response to Neuromodulation Therapy

Led by Lunair Medical · Updated on 2025-09-03

Participants Needed

Research Sites

52 weeks

Total Duration

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 therapys 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

Age: 18Years +

All Genders

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%

Research Team

Andrea Director of Clinical Operations

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Study of Obstructive Sleep Apnea in Latin American Adults and Their Response to Neuromodulation Therapy

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria