Neurostimulation for Sleep Disordered Breathing

NCT06883617 | Recruiting

• 1 other identifier: 10050
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disordered Breathing (SDB); Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Safety Endpoint - assessment of procedure or device related adverse events

  Incidence of adverse events (AEs) related to the Lunair system or procedure

  enrollment to 12 months post-implant

Secondary Outcomes (1)

• Improvement in sleep disordered breathing per sleep study

  six months, 12 month and 24 months post implant

Study Arms (1)

Alpha Lunair System implanted subjects

EXPERIMENTAL

Device: Neuro stimulator Implant

Interventions

Neuro stimulator Implant DEVICE

Neuro Stimulator for treating sleep disordered breathing

Alpha Lunair System implanted subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lunair Medical: lead

Study Sites (1)

Sanatorio Americano

Asunción, Paraguay, Paraguay

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Andrea Director of Clinical Operations

CONTACT

1-866-675-4430; andreas@lunairmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First-in-Human, prospective, multicenter, single arm, feasibility clinical study

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 19, 2025
• Study Start: January 13, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)