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van CCT (UK)

van CCT (UK)

A study on the influence of dynamic light on sleep an circadian rhythm, in long-stay patients on a haematology ward.

- candidate number10789
- NTR NumberNTR3217
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-dec-2011
- Secondary IDs2011-174 METC Erasmusmc
- Public TitleA study on the influence of dynamic light on sleep an circadian rhythm, in long-stay patients on a haematology ward.
- Scientific TitleA study on the influence of dynamic light on sleep an circadian rhythm, in long-stay patients on a haematology ward.
- ACRONYMDynamic light study
- hypothesisArtificial dynamic lightening can positively influence the sleep/wake cycle and reduce the disturbance of the circadian rhythm due to hospitalization.
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL), Acute Myeloid Leukemia (AML), Mantle cell lymphoma, Multiple myeloma, Intensive chemotherapy, Burkitt lymphoma
- Inclusion criteria1. Patient at least 18 yrs old;
2. Admitted to the haematology dept in a private patient room equipped with dynamic light as well as standard light;
3. Written informed consent;
4. Expected length of stay approx 3 weeks with room arrest;
5. Patients requiring intensive chemotherapy, due to AML, ALL, Burkitt lymphoma, mantle cell lymphoma, and multiple myeloma.
- Exclusion criteria1. Active depression;
2. Visual handicapped due to ocular pathologies like macula degeneration, severe cataract or severe diabetic retinopathy;
3. Sleep apnoe syndrome;
4. Extreme light sensitivity;
5. Insufficient fluency in Dutch language.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-jan-2012
- planned closingdate
- Target number of participants80
- InterventionsOn the haematology ward of the hospital, 9 single-bed rooms will be equipped with dynamic light as well as standard light. The design of the study is a randomized controlled trial. Patients will be randomized to dynamic light or standard light for their entire stay. If during a subsequent stay (ie second episode) patients participate again, they will be switched to the opposite condition.
- Primary outcomeDifference in wakefullness during the time presumed sleeping between both groups.
- Secondary outcome1. Subjective quality of sleep;
2. Depression;
3. Delirium as diagnosed by a psychiatrist;
4. Clinical parameters (complications, blood pressure, heart rate, temperature, pain score);
5. Duration of hospitalization;
6. Medication with special attention to benzodiazepines, antipsychotics, antidepressants, corticosteroids, and other medication with known psychiatric side effect (such as voriconazole).
- TimepointsEnrolment (demographic data, medical diagnosis, medication, sleep pattern by Municher Chronotype Questionaire, global clinical impression by staff).

During study:
1. Continuous:
Actigraphy by actiwatch, environmental parameters ie vertical and horizontal illuminance levels (due to daylight and/or artificial light), use of sunscreens and/or curtains, use and adjustment by patients/staff of all lighting systems in the room, room temperature, room humidity, position patient (bed or chair), outdoor vertical and horizontal illuminance levels;
2. Once daily:
Heart rate, blood pressure, temperature, quality of sleep (Groninger Sleep Quality Scale);
3. Two times per week:
Pain scored by numeric rating scale (NRS);
4. Weekly:
Hospital anxiety depression scale (HADS), delirium (as weekly revised by a psychiatrist), complications (as noted in the decursus), use of benzodiazepines, antipsychotics, antidepressants, corticosteroids, other medication, WHO performance score, frequency and duration of swith off the study light due to medical reasons or on patients request;
5. Once during admission:
Evaluation of lighting system itself by patients;
6. Periodical:
Noise, ventilation, air flow;
7. At the end of the study:
Global clinical impression by staff, length of stay;
8. In case of early cessation of patient participation:
Reason of cessation;
9. At the end of the entire study period:
Evaluation of lighting system by staff.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam, TNO Quality of Life (Work and Employment)
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, TNO
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD28-dec-2011 - 16-jan-2012

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