Neurostimulation treatment for sleep apnea

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

This clinical trial evaluates the safety and effectiveness of the Lunair Alpha System, a neurostimulator implant, for patients suffering from moderate to severe sleep disordered breathing. The study aims to provide an alternative treatment option for individuals who cannot tolerate or access traditional therapies for sleep apnea. Participants will be monitored for their response to the neurostimulation intervention, with assessments based on their sleep quality and breathing patterns. This is the first human trial of this innovative approach.

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 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.

Where it's running

• Sanatorio Americano
  Asunción, Paraguay, Paraguay Recruiting

Study contacts

• Study coordinator: Andrea Director of Clinical Operations
• Email: andreas@lunairmedical.com
• Phone: 1-866-675-4430

Similar studies

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

• Neurostimulation treatment for sleep-disordered breathing

  This trial will test whether the Lunair Alpha System, a small implanted neurostimulator, can reduce breathing problems during sleep for people with moderate to severe sleep apnea who cannot tolerate or access other treatments.

  Recruiting Lunair Medical · Panama City, Provincia de Panamá · NCT07243405

• Understanding the relationship between sleep disordered breathing and multiple health conditions

  This study is trying to see how sleep problems affect people's overall health and quality of life by looking at different health conditions in patients with sleep disordered breathing.

  Recruiting Xiangya Hospital of Central South University · Changsha · NCT06755840

• Oura Ring validation for sleep using gold-standard sleep tests

  This study tests how well the Oura Ring matches the gold-standard sleep test ( PSG ) in healthy adults and people with sleep apnea.

  Recruiting Ouraring Inc. · St Louis, Missouri · NCT07908199

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Sleep problems in PAH patients: how sleep breathing relates to PAH outcomes

  This study tests how sleep-disordered breathing and nocturnal oxygen changes relate to outcomes in adults with pulmonary arterial hypertension.

  Recruiting Chinese Pulmonary Vascular Disease Research Group · Beijing · NCT07852403

• Early screening for sleep-disordered breathing in kids at the dentist

  This study tests whether a simple kid-friendly questionnaire can flag risk for sleep-disordered breathing in children aged 8–13 when checked during a dental visit.

  Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT07581938

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.