Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT07243405
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07243405
Study Brief:
Protocol Section:
NCT07243405