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

• Sponsor: University of Basel (Other)
• Overall Status: Completed
• CT.gov ID: NCT01256983
• Collaborator: University Hospital, Basel, Switzerland (Other), University Hospital Inselspital, Berne (Other), University Hospital, Zürich (Other)
• Enrollment: 30
• Arms: 2
• Duration (Months): 33

Study Details

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
• 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: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jul 1, 2013

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 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

Outcome Measures

Primary Outcome Measures

1. Bedtime [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanna Burkhalter, PhD, University of Basel
• ClinicalTrials.gov Identifier: NCT01256983
• Other Study ID Numbers: SleepTx-1
• First Posted: Dec 9, 2010
• Last Update Posted: Mar 3, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Hanna Burkhalter, PhD, University of Basel: Sleep quality; Daytime Sleepiness
• Additional relevant MeSH terms: Sleep Wake Disorders

Study Results

Participant Flow

Recruitment Details	49 patients were recruited
Pre-assignment Detail	19 declined to participate after initial interest

Arm/Group Title	Light Box	No Intervention
Arm/Group Description	10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm	10000 Lux after day 63
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	12
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	Light Box	No Intervention	Total
Arm/Group Description	10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm	10000 Lux after day 63	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 86.7%	14 93.3%	27 90%
>=65 years	2 13.3%	1 6.7%	3 10%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.72 (10.33)	58.54 (14.91)	59.63 (12.65)
Sex: Female, Male (Count of Participants)
Female	7 46.7%	8 53.3%	15 50%
Male	8 53.3%	7 46.7%	15 50%
Region of Enrollment (participants) [Number]
Switzerland	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Bedtime
Description	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)
Time Frame	Mean Bedtimes over 21 days for each period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Light Box	No Intervention
Arm/Group Description	10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm	10000 Lux after day 63
Measure Participants	14	12
Getup time	7.44 (1.69)	7.24 (1.39)
Bedtime	22.98 (1.78)	22.48 (1.37)

Adverse Events

Time Frame	2 months
Adverse Event Reporting Description	2 months beginning with the start of the study.
Arm/Group Title	Bright Light Therapy		Wait-list Intervention
Arm/Group Description	Bright Light Therapy with 10000 lux beginning at day 21 until day 42		Wait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over.
All Cause Mortality
	Bright Light Therapy		Wait-list Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bright Light Therapy		Wait-list Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Bright Light Therapy		Wait-list Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.