Please select the eligibility criteria that correspond to the clinical trial below.
Title: Daily Light Intervention in Renal Transplant Recipients Having a Sleep-Wake Dysregulation
Brief Summary: Sleep-wake dysregulation is a disturbance in the roughly 24-hour cycle of the circadian rhythm. Well known disorders presenting a sleep-wake dysregulation are seasonal affective disorder, jet lag and shift work. These people experience a serious mood change when the seasons change. When the day-night rhythm is desynchronized, they have sleep disturbances, little energy, and often feel depressed. An established intervention to treat this disorder is bright light therapy. Light therapy is used for affective disorders for shift workers, jet lag symptomatology and for advancing or delaying desynchronized rhythms.Two proxy measures for sleep-wake dysregulation are sleep quality and daytime sleepiness. It is known from cross sectional studies that renal transplant (RTx) recipients have a prevalence between 30% to 62% of poor sleep quality measured by self report; a prevalence of impaired daytime functioning of 34% 12 and a prevalence of depressive symptomatology of 20% to 22%. Sleep-wake dysregulation in other chronically ill population are a risk factor for morbidity and mortality.

RTx nurses in the follow-up care are in the frontline for recipient's symptoms respectively problems. The psychosocial variables that should be addressed, having an association with morbidity and mortality are sleep, daytime functioning, adherence to immunosuppressive medication, exercise, smoking and depressive symptomatology.

In the following research project we will address the following gaps: the fact that nature of sleep disturbances in RTx recipients has never been assessed, that there is no prevalence available on sleep-wake dysregulation and that there is no data on bright light therapy intervention in RTx recipients.

Hypothesis: Renal transplant recipients having a sleep wake disregulation will have an improved sleep quality and less daytime sleepiness after 21 days of light therapy.


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:

* For phase 1: all renal transplant recipients transplanted at the University Hospital Basel, Bern and Zurich, speaking German and having an actual address on the follow-up list of the ambulatory center list.
* Renal transplant recipients who have poor Sleep quality and /or daytime sleepiness (phase 1: Cross sectional survey study) and had a Sleep assessment (phase 2: Cross sectional diagnostic interview study)
* Renal transplant recipients who participated in Phase 1 and 2 that were diagnosed with sleep wake dysregulation
* Renal transplant recipients with signed written informed consent.

Exclusion Criteria:

* RTx recipients, who participated in phase 2, will be excluded in the study if

  * they were diagnosed with sleep disorders as parasomnia, breathing disorders or movement disorders.
  * they were diagnosed with alcohol or substance abuse
  * they are blind or suffer from a severe vision impairment (cataract), which possibly limits the effect of the light intervention and patients taking photosensitive medications
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: B