Neurostimulation for Sleep Disordered Breathing (SDB)

Recruiting now · Not applicable

Conditions studied: Sleep Disordered Breathing (SDB), Sleep Apnea

In brief

This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.

Key facts

Study ID

NCT07243405

Run by

Lunair Medical

People needed

45

Starts

2025-07-30

Expected to finish

2027-12-31

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 judgement 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 the time of implant
• Subject has clinical evidence of immunodeficiency
• Any condition likely to require future MRI or diathermy
• Subject is pregnant
• Subject has 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

Where it is running

• Hospital Paitilla — Panama City, Provincia de Panamá, Panama (enrolling)

Full record on ClinicalTrials.gov

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