Neurostimulation for Sleep Disordered Breathing (SDB)

NCT ID: NCT07243405

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2027-12-31

Brief Summary

This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.

Conditions

Sleep Disordered Breathing (SDB); Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Alpha Lunair System implanted subjects

Group Type: EXPERIMENTAL

Neuro stimulator implant

Intervention Type: DEVICE

Neuro stimulator for treating sleep disordered breathing

Interventions

Neuro stimulator implant

Neuro stimulator for treating sleep disordered breathing

Intervention Type: DEVICE

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lunair Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Paitilla

Panama City, Provincia de Panamá, Panama

Site Status: RECRUITING

Countries

Panama

Central Contacts

Kris VP, Clinical Operations

Role: CONTACT

kriss@lunairmedical.com

1-866-675-4430

Facility Contacts

Kris VP, Clinical Operations

Role: primary

kriss@lunairmedical.com

1-866-675-4430

Other Identifiers

10138

Identifier Type: -

Identifier Source: org_study_id