Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation

NCT ID: NCT01256983

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-07-31

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.

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.

Conditions

Renal Disease; Sleep Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bright Light Therapy

Bright Light Therapy with 10000 lux beginning at day 21 until day 42

Group Type: EXPERIMENTAL

Bright Light Therapy

Intervention Type: BEHAVIORAL

10000 Lux for 30 Minutes according to sleep wake rhythm

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.

Group Type: OTHER

Wait-list intervention

Intervention Type: BEHAVIORAL

10000 Lux for 30 Minutes according to sleep wake rhythm

Interventions

Bright Light Therapy

10000 Lux for 30 Minutes according to sleep wake rhythm

Intervention Type: BEHAVIORAL

Wait-list intervention

10000 Lux for 30 Minutes according to sleep wake rhythm

Intervention Type: BEHAVIORAL

Other Intervention Names

Philips Energy Light; Philips Energy Light

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Hanna Burkhalter

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabina De De Geest, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nursing Science

References

Burkhalter H, Wirz-Justice A, Denhaerynck K, Fehr T, Steiger J, Venzin RM, Cajochen C, Weaver TE, De Geest S. The effect of bright light therapy on sleep and circadian rhythms in renal transplant recipients: a pilot randomized, multicentre wait-list controlled trial. Transpl Int. 2015 Jan;28(1):59-70. doi: 10.1111/tri.12443. Epub 2014 Oct 2.

Reference Type: DERIVED

PMID: 25182079 (View on PubMed)

Other Identifiers

SleepTx-1

Identifier Type: -

Identifier Source: org_study_id