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Neurostimulation for Sleep Disordered Breathing | Clinical Trials | Clareo Health

RECRUITINGNA

Neurostimulation for Sleep Disordered Breathing

The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing

NCT06883617•Lunair Medical

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

Sanatorio Americano

Asunción, Paraguay, Paraguay

Key Dates

Start Date

January 13, 2025

Primary Completion Date

April 30, 2026

Completion Date

December 15, 2027

Last Updated

March 20, 2025

Enrollment

ESTIMATED participants

Conditions

Sleep Disordered Breathing (SDB)Sleep Apnea

Interventions

Neuro stimulator Implant

DEVICE

Contacts

Andrea Director of Clinical Operations

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neurostimulation for Sleep Disordered Breathing

Inclusion Criteria

Exclusion Criteria

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