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New treatment option for Sleep Disordered Breathing (SDB)
Official title Neurostimulation for Sleep Disordered Breathing (SDB)
ClinicalTrials.gov ID: NCT07243405
What this study is testing
- What it's testing
- This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join if
- Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Panama City, Provincia de Panamá, Panama
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama City, Provincia de Panamá, Panama. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.