Skip to content

Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01256983
Acronym
SleepTx-1
Enrollment
30
Registered
2010-12-09
Start date
2010-10-31
Completion date
2013-07-31
Last updated
2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Disease, Sleep Disorders

Keywords

Sleep quality, Daytime Sleepiness

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.

Interventions

BEHAVIORALBright Light Therapy

10000 Lux for 30 Minutes according to sleep wake rhythm

BEHAVIORALWait-list intervention

10000 Lux for 30 Minutes according to sleep wake rhythm

Sponsors

University Hospital, Basel, Switzerland
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
University Hospital, Zürich
CollaboratorOTHER
University of Basel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
BedtimeMean Bedtimes over 21 days for each periodThe 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)

Participant flow

Recruitment details

49 patients were recruited

Pre-assignment details

19 declined to participate after initial interest

Participants by arm

ArmCount
Light Box
10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm
15
No Intervention
10000 Lux after day 63
15
Total30

Baseline characteristics

CharacteristicNo InterventionLight BoxTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants2 Participants3 Participants
Age, Categorical
Between 18 and 65 years
14 Participants13 Participants27 Participants
Age, Continuous58.54 years
STANDARD_DEVIATION 14.91
60.72 years
STANDARD_DEVIATION 10.33
59.63 years
STANDARD_DEVIATION 12.65
Region of Enrollment
Switzerland
15 participants15 participants30 participants
Sex: Female, Male
Female
8 Participants7 Participants15 Participants
Sex: Female, Male
Male
7 Participants8 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

Primary

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)

Time frame: Mean Bedtimes over 21 days for each period

ArmMeasureGroupValue (MEAN)Dispersion
Light BoxBedtimeGetup time7.44 HoursStandard Deviation 1.69
Light BoxBedtimeBedtime22.98 HoursStandard Deviation 1.78
No InterventionBedtimeGetup time7.24 HoursStandard Deviation 1.39
No InterventionBedtimeBedtime22.48 HoursStandard Deviation 1.37

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026