Neurostimulation for Sleep Disordered Breathing (ECLIPSE 1)

Lunair Medical

Status

Enrolling

Conditions

Sleep Disordered Breathing (SDB)

Sleep Apnea

Treatments

Device: Neuro stimulator Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT06883617

10050

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.