Neurostimulation treatment for sleep-disordered breathing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with moderate to severe sleep-disordered breathing confirmed by polysomnography will receive an implant of the Lunair Alpha neurostimulator and be followed for safety and breathing outcomes. The study will monitor changes in apnea-hypopnea index, sleep quality, and adverse events after device implantation. Enrollment targets people who are not tolerating or do not have access to standard SDB therapies such as CPAP. Investigators will exclude participants on opioids or other medications that affect respiration, those requiring chronic oxygen, recent upper airway surgery, or other conditions that confound sleep assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Paitilla
  Panama City, Provincia de Panamá, Panama Recruiting

Study contacts

• Study coordinator: Kris VP, Clinical Operations
• Email: kriss@lunairmedical.com
• Phone: 1-866-675-4430

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.