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Recruiting EARLY_Phase 1 NCT06762873

Assessment of OSA in Latin American and Response to Neuromod Therapy

◆ AI Clinical Summary

This study looks at how sleep apnea affects the airways of people from Latin America who have moderate to severe obstructive sleep apnea (OSA). Researchers will test a new neuromodulation therapy, which uses nerve stimulation to help treat sleep apnea and improve breathing during sleep.

Key Objective: This trial is testing whether neuromodulation therapy can reduce sleep apnea symptoms and improve breathing in Latin American patients with moderate to severe OSA.

Who to Consider: People from Latin American backgrounds with moderate to severe obstructive sleep apnea who are interested in trying a new nerve-stimulation based treatment should consider enrolling.

Trial Parameters

Condition Obstructive Sleep Apnea
Sponsor Lunair Medical
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-21
Completion 2024-12-31
Interventions
Drug Induced Sleep Endoscopy with PNS

Brief Summary

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

Inclusion Criteria: 1. Subject is aged ≥ 18 years old 2. Subject is willing and able to provide informed consent 3. Subject is geographically stable 4. Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and/or behavioral treatments) 5. Subject has an Apnea-Hypopnea Index (AHI) score ≥15 \< 100 events per hour on Screening PSGs (under AASM 4%) based on in-lab polysomnography studies Exclusion Criteria: 1. Subject is currently implanted with another active implantable device. 2. Subject is actively enrolled in another premarket investigational study (medical device or drug) unless approved by Sponsor in writing. 3. Subject is considered vulnerable such as incarcerated or cognitively impaired. 4. 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

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