Melatonin and Quality of Life in Dialysis Patients
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.
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
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Sleep Problems
Intervention
Melatonin tablet 3 mg once daily, Placebo comparator
Location
Meander Medical Center
Amersfoort
Netherlands
3800 BM
Status
Recruiting
Source
Meander Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00388661
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Melatonin
A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant.
Sleep Stages
Periods of sleep manifested by changes in EEG activity and certain behavioral correlates; includes Stage 1: sleep onset, drowsy sleep; Stage 2: light sleep; Stages 3 and 4: delta sleep, light sleep, deep sleep, telencephalic sleep.
Receptors, Melatonin
A family of G-protein-coupled receptors that are specific for and mediate the effects of MELATONIN. Activation of melatonin receptors has been associated with decreased intracellular CYCLIC AMP and increased hydrolysis of PHOSPHOINOSITIDES.
Sleep Disorders, Intrinsic
Dyssomnias (i.e., insomnias or hypersomnias) associated with dysfunction of internal sleep mechanisms or secondary to a sleep-related medical disorder (e.g., sleep apnea, post-traumatic sleep disorders, etc.). (From Thorpy, Sleep Disorders Medicine, 1994, p187)
Smith-magenis Syndrome
Complex neurobehavioral disorder characterized by distinctive facial features (FACIES), developmental delay and mental retardation. Behavioral phenotypes include sleep disturbance, maladaptive, self-injurious and attention-seeking behaviors. The sleep disturbance is linked to an abnormal circadian secretion pattern of MELATONIN. The syndrome is associated with de novo deletion or mutation and HAPLOINSUFFICIENCY of the retinoic acid-induced 1 protein on chromosome 17p11.2.
Clinical Trials
The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
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...
The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.
Melatonin and the Metabolic Syndrome
Melatonin is a hormone that regulates some body functions, including the sleep/wake cycle. Some people take melatonin supplements (over the counter) for promoting sleep. Some studies sugg...
Melatonin for Sleep in Children With Autism
The purpose of this study is to determine if liquid supplemental melatonin is an effective treatment for children with autism who have sleep problems related to insomnia (difficulty fallin...
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps...
PubMed Articles
The Use of Exogenous Melatonin in Delayed Sleep Phase Disorder: A Meta-analysis.
STUDY OBJECTIVES: To perform a meta-analysis of the efficacy and safety of exogenous melatonin in advancing sleep-wake rhythm in patients with delayed sleep phase disorder. DESIGN: Meta analysis of pa...
Dose finding of melatonin for chronic idiopathic childhood sleep onset insomnia: an RCT.
RATIONALE: Pharmacokinetics of melatonin in children might differ from that in adults. OBJECTIVES: This study aims to establish a dose-response relationship for melatonin in advancing dim light melato...
Melatonin Prolonged Release : In the Treatment of Insomnia in Patients Aged ≥55 years.
Melatonin prolonged release (PR) 2 mg is approved for the treatment of primary insomnia characterized by poor sleep quality in patients aged ≥55 years in the EU and elsewhere. Patients may receive...
ABSTRACT: BACKGROUND: Melatonin is extensively used in the USA in a non-regulated manner for sleep disorders. Prolonged release melatonin (PRM) is licensed in Europe and other countries for the short...
PURPOSE: We aimed to analyse the in vitro fertilization-embryo transfer (IVF-ET) outcomes of the patients with sleep disturbances who were administered melatonin. METHODS: A total of 60 patients with...
