Recruiting NCT07243405
Neurostimulation for Sleep Disordered Breathing (SDB)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuro stimulator implant.
- Who it may be relevant to
- Registry conditions: Sleep Disordered Breathing (SDB), Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Panama
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing
Overview
This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
Interventions
- Device Neuro stimulator implant
Neuro stimulator for treating sleep disordered breathing
Primary outcome measures
- Safety Endpoint - assessment of procedure or device related adverse events [Time frame: enrollment to 12 months post-implant]
Secondary outcome measures (1)
- Improvement in sleep disordered breathing per sleep study [Time frame: six month, 12 month and 24 month post implant]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Panama · 1 center
- Hospital Paitilla — Panama City
Identifiers
NCT: NCT07243405 · 10138