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 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT00388661
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent
* Man/Women between 18 and 85 years
* Understanding and knowledge of the dutch language
* End Stage Renal Disease, stable chronic hemodialysis \> 3 months
* SpKt/V(total) \> 1,2 pro dialysis
* Validated actometer shows that sleep efficiency \< 90% or sleep latency \> 15 minutes or fragmentation index \> 25 points
Exclusion Criteria:
* Known major illness, which interferes with patient's participation in the study according to the investigator)or which results in a probable patient's survival of less than 1 year.
* Instable angina pectoris, heart failure NYHA class IV
* Pregnancy
* Current use of melatonin of known allergy of melatonin
* Participation in other medication/drug research within a month before inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00388661
Study Brief:
Protocol Section:
NCT00388661