Melatonin and Quality of Life in Dialysis Patients
Condition: Sleep Problems; Haemodialysis
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional
Phase: Phase 3

Summary: 
      Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis
      patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For
      a good regulation of these circadian rhythms a uniform external synchronisation is necessary.
      This is the synchronisation of the biological clock of our body by light and other
      influences. In case of a disturbance of the external synchronisation, due to for example naps
      during the day or wake periods at night, internal rhythms can be unlinked. As a result a
      weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis
      patients have sleep problems. Their sleep latency is prolonged. They often take a nap during
      the day and their sleep efficiency is poor. There has only been one study on the melatonin
      rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of
      dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this
      study no link was made between melatonin rhythm and the nature and severity of possible sleep
      problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm,
      exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal
      biological clock and a better quality of life.

      The aim is to improve quality of life of hemodialysis patients with a placebo-controlled
      study with melatonin to investigate if exogenous melatonin can improve sleep problems and on
      the longer term improve quality of life (and secondary morbidity) of dialysis patients.
    

Detailed description: 
      Objective of the study:

      Does melatonin by improving sleep parameters improve quality of life of hemodialysis
      patients?

      Study design:

      Placebo-controlled, double-blind, randomized trial

      Study population:

      hemodialysis patients

      Intervention:

      melatonin 3 mg once daily (or placebo)

      Primary study parameters/outcome of the study:

        1. improvement of vitality (dimension quality of life) by 15 points (RAND SF 36)

        2. improvement general health by 15 points (dimension quality of life, RAND SF 36)

      Secondary study parameters/outcome of the study:

        1. Change in biochemical parameters

        2. Change in ProBNP

        3. Change in nutritional status

        4. Change in use of medication

        5. Change in preload
    

Intervention name(s): Melatonin tablet 3 mg once daily; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Melatonin tablet 3 mg once daily; Placebo comparator
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep problems; quality of life; melatonin; sleep apnea; medication; preload; nutritional status; ProBNP