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Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation (SleepTx-1)

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ClinicalTrials.gov Identifier: NCT01256983
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : January 28, 2014
Last Update Posted : March 3, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Renal Disease Sleep Disorders Behavioral: Bright Light Therapy Behavioral: Wait-list intervention Early Phase 1

Detailed Description:

This research project has three phases:

The first phase is a cross sectional survey including all patients transplanted in Basel, Bern and in Zurich speaking German and transplanted at least 6 months ago. Renal transplant recipients having poor sleep quality and / or daytime sleepiness as result of this first phase will be asked to participate in phase two. Phase two is an sleep assessment, resulting in a presumed sleep diagnosis.

Renal transplant recipients having a sleep wake dysregulation, assessed in phase two, will be asked to participate in phase three. Phase three is a pilot randomized controlled trial to compare the sustained impact of bright light therapy on sleep-wake regulation.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Daily Light Intervention in Renal Transplant Recipients Having a Sleep-Wake Dysregulation
Study Start Date : October 2010
Primary Completion Date : June 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bright Light Therapy
Bright Light Therapy with 10000 lux beginning at day 21 until day 42
Behavioral: Bright Light Therapy
10000 Lux for 30 Minutes according to sleep wake rhythm
Other Name: Philips Energy Light
Wait-list intervention
Wait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over.
Behavioral: Wait-list intervention
10000 Lux for 30 Minutes according to sleep wake rhythm
Other Name: Philips Energy Light

Outcome Measures

Primary Outcome Measures :
  1. Bedtime [ Time Frame: Mean Bedtimes over 21 days for each period ]

    The mean "bedtime" assessed by actimetry of each 3 week period (day 21, 42, 63 ) was used as outcome to be compared with the control group.

    Bedtime is expressed in time (hours and minutes)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256983

Sponsors and Collaborators
University of Basel
University Hospital, Basel, Switzerland
University Hospital Inselspital, Berne
University Hospital, Zürich
Principal Investigator: Sabina De De Geest, PhD Institute of Nursing Science
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanna Burkhalter, PhD, University of Basel
ClinicalTrials.gov Identifier: NCT01256983     History of Changes
Other Study ID Numbers: SleepTx-1
First Posted: December 9, 2010    Key Record Dates
Results First Posted: January 28, 2014
Last Update Posted: March 3, 2014
Last Verified: January 2014

Keywords provided by Hanna Burkhalter, University of Basel:
Sleep quality
Daytime Sleepiness

Additional relevant MeSH terms:
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders