Please select the arm or intervention descriptions that belong 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: Arm Label: extended hours; Type: EXPERIMENTAL; Interventions: Procedure: haemodialysis | Arm Label: standard hours; Type: ACTIVE_COMPARATOR; Interventions: Procedure: haemodialysis | Intervention Type: PROCEDURE; Name: haemodialysis; Assigned to Arm(s): extended hours, standard hours
B: Arm Label: Bright Light Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Bright Light Therapy | Arm Label: Wait-list intervention; Type: OTHER; Interventions: Behavioral: Wait-list intervention | Intervention Type: BEHAVIORAL; Name: Bright Light Therapy; Assigned to Arm(s): Bright Light Therapy | Intervention Type: BEHAVIORAL; Name: Wait-list intervention; Assigned to Arm(s): Wait-list intervention
C: Arm Label: Dopamine Agonist Group; Type: EXPERIMENTAL; Interventions: Other: Dopamine Agonist and Exercise | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Other: Dopamine Agonist and Exercise | Intervention Type: OTHER; Name: Dopamine Agonist and Exercise; Assigned to Arm(s): Dopamine Agonist Group, Placebo Group
D: Intervention Type: DRUG; Name: Melatonin; Assigned to Arm(s): N/A

Answer: B