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

January 29, 2014 updated by: Hanna Burkhalter, University of Basel

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Philips Energy Light
Other: 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 Names:
  • Philips Energy Light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Mean Bedtimes over 21 days for each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Collaborators

University Hospital Inselspital, Berne
University Hospital, Basel, Switzerland
University Hospital, Zürich

Investigators

  • Principal Investigator: Sabina De De Geest, PhD, Institute of Nursing Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SleepTx-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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