CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 30 enrolled
Drug / intervention
Bright Light Therapy +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT01256983
NCT01256983Early Ph 1Completed

Daily Light Intervention in Renal Transplant Recipients Having a Sleep-Wake Dysregulation

University of Basel·interventional·Posted Dec 9, 2010·Updated Mar 3, 2014

In Brief

A Early Phase 1 clinical trial evaluating Bright Light Therapy and Wait-list intervention for Renal Disease and Sleep Disorders. Completed, enrolled 30 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Early Ph 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 9, 2010
Enrollment StartOct 1, 2010
Primary CompletionJun 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.6 years ago

Interventions

Bright Light Therapybehavioral

10000 Lux for 30 Minutes according to sleep wake rhythm

Wait-list interventionbehavioral

10000 Lux for 30 Minutes according to sleep wake rhythm