Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation

NCT01256983 | Completed Early Phase 1 Results DMC

• 1 other identifier: SleepTx-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Disease; Sleep Disorders

Keywords

Sleep quality; Daytime Sleepiness

Outcome Measures

Primary Outcomes (1)

• Bedtime

  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

Study Arms (2)

Bright Light Therapy

EXPERIMENTAL

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

Behavioral: Bright Light Therapy

Wait-list intervention

OTHER

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

Interventions

Bright Light Therapy BEHAVIORAL

10000 Lux for 30 Minutes according to sleep wake rhythm

Also known as: Philips Energy Light

Bright Light Therapy

Wait-list intervention BEHAVIORAL

10000 Lux for 30 Minutes according to sleep wake rhythm

Also known as: Philips Energy Light

Wait-list intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Basel: lead
• University Hospital, Basel, Switzerland: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital, Zürich: collaborator

Related Publications (1)

• 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.

  PMID: 25182079 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Limitations and Caveats

The study was very long and burdensome for the participants, a full powered study should be shorter.

Results Point of Contact

• Title: Mrs. Hanna Burkahlter
• Organization: University Hospital Zürich

hanna.burkhalter@usz.ch

0041 76 371 12 35

Study Officials

• Sabina De De Geest, PhD

  Institute of Nursing Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 3, 2014
• Results First Posted: January 28, 2014

Record last verified: 2014-01