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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University Hospital, Zürich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light Therapy | Experimental | Bright Light Therapy with 10000 lux beginning at day 21 until day 42 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light Therapy | Behavioral | 10000 Lux for 30 Minutes according to sleep wake rhythm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
RTx recipients, who participated in phase 2, will be excluded in the study if
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| Name | Affiliation | Role |
|---|---|---|
| Sabina De De Geest, PhD | Institute of Nursing Science | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25182079 | Derived | 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. |
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19 declined to participate after initial interest
49 patients were recruited
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Box | 10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm |
| FG001 | No Intervention | 10000 Lux after day 63 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Box | 10000 lux after day 21 Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm |
| BG001 | No Intervention | 10000 Lux after day 63 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | Hours | Mean Bedtimes over 21 days for each period |
|
2 months
2 months beginning with the start of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bright Light Therapy | Bright Light Therapy with 10000 lux beginning at day 21 until day 42 |
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The study was very long and burdensome for the participants, a full powered study should be shorter.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs. Hanna Burkahlter | University Hospital Zürich | 0041 76 371 12 35 | hanna.burkhalter@usz.ch |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D012893 | Sleep Wake Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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| Wait-list intervention | Behavioral | 10000 Lux for 30 Minutes according to sleep wake rhythm |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. | 0 | 15 | 0 | 15 |
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| D052801 | Male Urogenital Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |