Renal DiseaseEarly Phase 1SleepTx-1NCT01256983
Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation
A Early Phase 1 study testing Bright Light Therapy and Wait-list intervention in people with Renal Disease and Sleep Disorders, run by University of Basel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease, Sleep Disorders
- What is being tested?
- Bright Light Therapy and Wait-list intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jul 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Daily Light Intervention in Renal Transplant Recipients Having a Sleep-Wake Dysregulation
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.
Read more
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.
Read the 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
- Being tested
- Bright Light Therapy, Wait-list intervention
- Keywords
- Sleep quality, Daytime Sleepiness
- Medical subject headings
- Kidney Diseases, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light TherapyBehavioural
Also called Philips Energy Light
10000 Lux for 30 Minutes according to sleep wake rhythm
Wait-list interventionBehavioural
Also called Philips Energy Light
10000 Lux for 30 Minutes according to sleep wake rhythm
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Therapy | Experimental | Bright Light Therapy with 10000 lux beginning at day 21 until day 42 Receives: 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. Receives: Behavioral: Wait-list intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Mean Bedtimes over 21 days for each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern, University Hospital, Zürich
- Responsible party
- Principal investigator, Hanna Burkhalter, University of Basel
- Investigators
- Sabina De De Geest, PhD, Principal investigator, Institute of Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256983
- Sponsor's protocol ID
- SleepTx-1
- Acronym
- SleepTx-1
- Status last verified
- Jan 2014
- First submitted
- 8 Dec 2010
- Last updated
- 3 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25182079
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Light Intervention in Renal Transplant Recipients Having a Sleep-Wake Dysregulation
- ClinicalTrials.gov ID
- NCT01256983
- Acronym / sponsor ID
- SleepTx-1 / SleepTx-1
- Conditions
- Renal Disease, Sleep Disorders
- Keywords
- Sleep quality, Daytime Sleepiness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern, University Hospital, Zürich
- Study start
- Oct 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 28 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy | Experimental | Behavioral: Bright Light TherapyBright Light Therapy with 10000 lux beginning at day 21 until day 42 |
| Wait-list intervention | Other | Behavioral: Wait-list interventionWait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- RTx recipients, who participated in phase 2, will be excluded in the study if
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light TherapyAlso: Philips Energy Light10000 Lux for 30 Minutes according to sleep wake rhythm | Behavioural | Bright Light Therapy |
| Wait-list interventionAlso: Philips Energy Light10000 Lux for 30 Minutes according to sleep wake rhythm | Behavioural | Wait-list intervention |
Primary outcome
Bedtime
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25182079Burkhalter 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina De De Geest, PhD principal investigator
Institute of Nursing Science
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bright Light Therapy and Wait-list intervention in people with Renal Disease and Sleep Disorders, run by University of Basel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bedtime (time frame: Mean Bedtimes over 21 days for each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014.