Neurostimulation treatment for sleep apnea
The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing
This study tests a new implant that uses neurostimulation to see if it can help people with moderate to severe sleep apnea who can't use regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lunair Medical Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Asunción, Paraguay) |
| Trial ID | NCT06883617 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the Lunair Alpha System, a neurostimulator implant, for patients suffering from moderate to severe sleep disordered breathing. The study aims to provide an alternative treatment option for individuals who cannot tolerate or access traditional therapies for sleep apnea. Participants will be monitored for their response to the neurostimulation intervention, with assessments based on their sleep quality and breathing patterns. This is the first human trial of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with moderate to severe sleep disordered breathing who are unable to tolerate or access other treatment options.
Not a fit: Patients currently taking opioids, narcotics, or medications that affect sleep and respiration may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new solution for patients with sleep apnea who do not respond to conventional therapies.
How similar studies have performed: While this approach is novel, previous studies on neurostimulation for sleep apnea have shown promising results.
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 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.
Where this trial is running
Asunción, Paraguay
- Sanatorio Americano — Asunción, Paraguay, Paraguay (Recruiting)
Study contacts
- Study coordinator: Andrea Director of Clinical Operations
- Email: andreas@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.