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:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT06711159
Eligibility Criteria:
Inclusion Criteria:
For a subject to be eligible, all inclusion criteria must be answered "yes":
1. Age ≥18 years
2. Subjects must be diagnosed with Severe Obstructive Sleep Apnea (AHI \> 30) and have not yet started any form of PAP (positive airway pressure) treatment.
3. ESS score must be above 10 at the time of inclusion.
Exclusion Criteria:
For a subject to be eligible, all exclusion criteria must be answered "no":
1. Known severe neurological or psychiatric diseases.
2. Known congestive heart failure, chronic renal failure, liver failure, malignancy, severe pulmonary disease.
3. Considerable use of alcohol.
4. Medication judged by investigator to influence sleep/wake regulation to such a degree that data quality will be compromised.
5. Has cochlear implants.
6. Involved in therapies with medical devices that deliver electrical energy into the area around the implant.
7. Is at high risk of surgical complications, such as active systemic infection and haemorrhagic disease.
8. Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
9. Has an infection at the site of device implantation.
10. Operates MRI scanners.
11. Has a profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkelling is allowed to 5 metres depth.
12. Has a profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).
13. Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
14. Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
15. Pregnancy or intention to become pregnant within the next 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06711159
Study Brief:
Protocol Section:
NCT06711159