Sleep Apnea, Sleep Disordered Breathing (SDB)
Conditions
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.
Interventions
DEVICENeuro stimulator Implant
Neuro Stimulator for treating sleep disordered breathing
Sponsors
Lunair Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
First-in-Human, prospective, multicenter, single arm, feasibility clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint - assessment of procedure or device related adverse events | enrollment to 12 months post-implant | Incidence of adverse events (AEs) related to the Lunair system or procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in sleep disordered breathing per sleep study | six months, 12 month and 24 months post implant | Improvement in sleep disordered breathing at 6, 12 and 24 months post implant during an attended sleep study |
Countries
Paraguay
Contacts
Primary ContactAndrea Director of Clinical Operations
Outcome results
None listed