Melatonin Pharmacokinetics in Dialysis Patients

Completed

• Conditions: Hemodialyse; 10038430

• Registration Number: NL-OMON40235
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

Hemodialysis patients
Age: 18-85 years
Informed consent
Good knowledge of dutch language
Melatonine use for at least 12 weeks

Exclusion Criteria

Severe comorbidy such as heart failure class IV, instable AP, pulmonal, psychiatric or neurologic disease
Blindness
Nocturnal dialysis
Documented sleep apnea
Alcohol or drug abuse
Use of hypnotics such as benzodiazepines

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Melatonin concentration measured in saliva versus time of day during 24 hours.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Melatonin concentration measured in salvia, calculating area under the curve<br /><br><br /><br>Change in baseline melatonin concentration (comparising melatonin concentration<br /><br>t=15:00 of 3 different days)<br /><br><br /><br>Objective sleepparameters using actometer and the relation to melatonin<br /><br>kinetics.<br /><br><br /><br>Subjective sleepscore using ESS questionaire and chronotype and the relation to<br /><br>melatonin kinetics.</p><br>