Status:
RECRUITING
Neurostimulation for Sleep Disordered Breathing
Lead Sponsor:
Lunair Medical
Conditions:
Sleep Disordered Breathing (SDB)
Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06883617
Start Date
January 13 2025
End Date
December 15 2027
Last Update
March 20 2025
Active Locations (1)
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1
Sanatorio Americano
Asunción, Paraguay, Paraguay