Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
Brief 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 research the endogenous melatonin rhythm and to improve sleep problems of hemodialysis patients with a placebo-controlled study with exogenous melatonin. Next to this a substudy is performed, in which the effect of the change of daytime to nocturnal in hospital hemodialysis on sleep and melatonin is researched.


Options:
A: Inclusion Criteria:

1. Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD
2. Aged 18 years or older
3. Undergoing dialysis for 18 hours per week or less
4. Suitable for either extended or standard dialysis in the view of the treating physician
5. Agreeable to randomisation

Exclusion Criteria:

1. Life expectancy of less than 6 months
2. Definite plans to undergo renal transplantation within 12 months of entry to the study
3. Inability to complete quality of life questionnaire
4. Concomitant major illness that would limit assessments and followup
5. High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.
B: Inclusion Criteria:

* Candidate on the United Network for Organ Sharing (UNOS) wait list for a kidney or kidney-pancreas or evaluated as eligible for candidacy at the UMN
* Aged 18 or older
* English-speaking
* Literate
* Mentally intact
* Able to use the telephone to participate in 6 weekly teleconferences
* Able to attend 2 in-person classes in a Minnesota Metro area
* Able to comply with study monitoring requirements
* Receiving standard medical follow-up care
* Willing to complete the informed consent process

Exclusion Criteria:

* Prior transplant
* Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major non-transplant surgery planned in the next 3 months)
* Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse
* Not expected to be on the waiting list \> 3 months (e.g., acceptable living donor has been identified and scheduled)
* Prior MBSR class or regularly practicing mindfulness meditation (twice a week or more)
* Not receiving standard medical care.
C: Inclusion Criteria:

* Clinically stable hemodialysis patients with positive diagnosis in IRLSS questionnaire for the RLS will be eligible to participate. Entry criteria included being on chronic hemodialysis for six months, able to perform an exercise training, with dialysis delivery (KT/V) \> 1.1.

Exclusion Criteria:

* Patients were excluded from the study if they were diagnosed with neuropathies or reasons for being in a catabolic state (including malignancies, HIV and opportunistic infections, active inflammation), within 3 months prior to the start of the study. In addition patients treated with drugs recommended for the treatment of RLS as well as patients with Parkinson's disease or untreated depression will be also excluded.
D: Inclusion Criteria:

* Stable Peritoneal dialysis
* Stable Hemodialysis
* Age 18-85 years

Exclusion Criteria:

* use of hypnotics, MAO inhibitors or neuroleptics
* Liver disease
* Participation in drug investigation \< 1 months to start
* Former use of melatonin
* Severe neurological/psychiatric disease
* Allergic to melatonin or additives

Answer: D