Neurostimulation treatment for sleep-disordered breathing
The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing
NA · Lunair Medical · NCT07243405
This trial will test whether the Lunair Alpha System, a small implanted neurostimulator, can reduce breathing problems during sleep for people with moderate to severe sleep apnea who cannot tolerate or access other treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lunair Medical (industry) |
| Drugs / interventions | radiation |
| Locations | 1 site (Panama City, Provincia de Panamá) |
| Trial ID | NCT07243405 on ClinicalTrials.gov |
What this trial studies
Participants with moderate to severe sleep-disordered breathing confirmed by polysomnography will receive an implant of the Lunair Alpha neurostimulator and be followed for safety and breathing outcomes. The study will monitor changes in apnea-hypopnea index, sleep quality, and adverse events after device implantation. Enrollment targets people who are not tolerating or do not have access to standard SDB therapies such as CPAP. Investigators will exclude participants on opioids or other medications that affect respiration, those requiring chronic oxygen, recent upper airway surgery, or other conditions that confound sleep assessments.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate-to-severe sleep-disordered breathing confirmed by PSG who do not tolerate or lack access to other treatments and who are medically stable without chronic oxygen needs or contraindicating medications.
Not a fit: Patients taking opioids or other medications that affect breathing, those who need chronic supplemental oxygen, have other confounding sleep disorders, recent upper airway surgery, or severe chronic kidney disease are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could provide an alternative treatment that reduces apneas and improves sleep for patients who cannot use standard therapies.
How similar studies have performed: Related implantable neurostimulation approaches (for example hypoglossal nerve stimulation) have shown benefit in selected patients, so the general approach has precedent even if the Lunair Alpha System itself is new.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Panama City, Provincia de Panamá
- Hospital Paitilla — Panama City, Provincia de Panamá, Panama (RECRUITING)
Study contacts
- Study coordinator: Kris VP, Clinical Operations
- Email: kriss@lunairmedical.com
- Phone: 1-866-675-4430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Disordered Breathing, Sleep Apnea