NCT06883617 Neurostimulation for Sleep Disordered Breathing
| NCT ID | NCT06883617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lunair Medical |
| Condition | Sleep Disordered Breathing (SDB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-01-13 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06883617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Disordered Breathing (SDB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883617 currently recruiting?
Yes, NCT06883617 is actively recruiting participants. Contact the research team at andreas@lunairmedical.com for enrollment information.
Where is the NCT06883617 trial being conducted?
This trial is being conducted at Asunción, Paraguay.
Who is sponsoring the NCT06883617 clinical trial?
NCT06883617 is sponsored by Lunair Medical. The trial plans to enroll 45 participants.