Neurostimulation for Sleep Disordered Breathing

Launched by LUNAIR MEDICAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called the Lunair Alpha System for people who suffer from moderate to severe sleep disordered breathing, which includes conditions like sleep apnea. The goal is to see if this system is safe and effective for helping patients breathe better during sleep. The study is currently recruiting participants aged 65 to 74 who have not been able to tolerate or comply with other treatments for their condition.

To be eligible for the trial, participants must have been diagnosed with moderate to severe sleep disordered breathing through a sleep study. However, there are some important criteria that could exclude individuals from participating, such as taking certain medications that affect sleep, having recent surgeries in the upper airway, or having other serious health issues. Those who join the study can expect to undergo assessments and receive the new treatment while being monitored for safety and effectiveness. It’s essential for interested individuals to discuss their health history with their doctor to see if they qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject does not tolerate, not compliant to or have access to alternative Sleep Disordered Breathing treatments
• • Subject has moderate to severe sleep disordered breathing as diagnosed by PSG
• Exclusion Criteria:
• • Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
• • Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate
• • Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.
• • Subject has a need for chronic supplemental oxygen therapy for any reason
• • Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness
• • Subject has severe chronic kidney disease
• • Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study.
• • Subject conducts work or regular activities requiring vigilance
• • Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.
• • Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices
• • Subject has an active systemic infection at time of implant.
• • Subject has clinical evidence of immunodeficiency.
• • Any condition likely to require future MRI or diathermy
• • Subject is pregnant
• • Subject has a severe nasal obstruction that could restrict airflow
• • Subject has any trauma to the upper airway
• • Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.