Actively Recruiting
Neurostimulation for Sleep Disordered Breathing
Led by Lunair Medical · Updated on 2025-03-20
45
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neurostimulation for Sleep Disordered Breathing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sanatorio Americano
Asunción, Paraguay, Paraguay
Actively Recruiting
Research Team
A
Andrea Director of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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