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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03022058
Eligibility Criteria:
Inclusion Criteria:
For a subject to be eligible, all inclusion criteria must be answered "yes":
1. Informed consent obtained before any study related activities1
2. Age 18-70 years
3. Patients with type 1 diabetes (duration ≥ 5 years)
Exclusion Criteria:
For a subject to be eligible, all exclusion criteria must be answered "no":
1. Severe cardiac disease
1. History of myocardial infarction
2. Cardiac arrhythmia
2. Previous stroke or cerebral haemorrhage and any other structural cerebral disease
3. Uraemia defined as s-creatinine ≥ 3 times upper reference value,
4. Liver disease defined as s-ALAT ≥ 3 times upper reference interval
5. Epilepsy
6. Use of antiepileptic drugs for any purposes
7. Use of the following drugs: Chemotherapeutic drugs of any kind, methotrexate, third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
8. Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the DHA1 or any other neuro-active substances
9. Use of hearing aid or cochlear implants2
10. Allergic contact dermatitis caused by metals or generally prone to skin irritation
11. Narrow or malformed ear canals
12. Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
13. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03022058
Study Brief:
Protocol Section:
NCT03022058