ROOM-LIGHT: Dynamic LED-light as Treatment for Depressed Patients in Inpatient Wards (ROOM-LIGHT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03363529|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Depression is a major health challenge, and despite developments in pharmacotherapy and psychotherapy a substantial part of patients will only recover very slowly and incompletely, and 10-25 % of the patients are resistant to treatment. Therefore, new treatment initiatives are in demand. Chronotherapeutics can regulate diurnal rhythms and sleep, and have shown promising results on antidepressant effects. Among chronotherapeutic treatment modalities, Bright Light Therapy (BLT) has been used in treatment of depression and sleep disorders for several decades with both an antidepressant and a sleep improving effect. BLT has also been shown to augment antidepressant therapy.
Objectives. The objective of this trial is to investigate the feasibility of a combination of LED-light armatures aiming to mimic sunlight, when installed in the patient rooms of a psychiatric inpatient Ward. Investigators has opted for using a randomized design that will subsequently be tested in a larger clinical trial with depression severity as the primary outcome. In this feasibility study investigators will register the stability of the system, the influence of the light on patients regarding tolerability, comfort, depression level, and sleep. Investigators also so want to measure and collect specific light-data on the Non-image-forming light (NIF) by using specially designed light sensors to capture the spectral distribution of the light. Finally investigators will test the electronic case report form (eCRF) that has been designed for the trial.
Design. The design is a randomised controlled feasibility trial with two arms: an active dynamic light trial arm and a standard light trial arm with blinding of depression outcome assessors (Hamilton depression rating scale), data collection, and data analyses. Randomization will be with a rate for active and standard of 2 to 1.
|Condition or disease||Intervention/treatment||Phase|
|Depression Light; Therapy, Complications Sleep Disorders, Circadian Rhythm||Device: Dynamic light Device: Standard||Not Applicable|
Inclusion and exclusion criteria. Inclusion: Major depression disorder, age > 18 years, informed consent and Danish speaking.
Exclusion: Severe suicidality, actual psychotic state, bipolar disorder and if the patient is subject to coercive measures of any kind.
Name and description of experimental and control intervention. The experimental intervention is the implementation of a dynamic LED-light system in two patient rooms. The system includes three elements: a window jamb built-in light panel, two ceiling mounted lamps, and a wall mounted lamp. All lamps will have a dynamic, time dependent frequency distribution and intensity of light. The control intervention is constant standard LED-light with two elements: two ceiling mounted lamps and a wall mounted lamp.
Primary and secondary outcomes.
1. Rate of patients discontinuing the trial due to discomfort from the lighting condition.
- Mean scores on the visual comfort scale in the intervention period
- Reduction in HAM-D17 scores from baseline to week 4 Trial size. In total 15 patients. All regulatory approvals has been met from the Danish Data Protection Agency, the regional Ethics Committee Agency, and the Mental Health Services of Copenhagen.
Time schedule. The first participant is expected to be enrolled in December 2017. The expected last follow-up of the last participant will be June 2018. Data will be analysed from June 2018 till December 2018. Manuscripts will be prepared from June 2017 and we expect to submit first manuscript January 2019.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Standard versus dynamic lighting|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Hamilton depression interview is done by external assessor blinded to condition|
|Official Title:||ROOM-LIGHT: Dynamic LED-light as Treatment for Depressed Patients in Inpatient Wards: A Feasibility Trial|
|Actual Study Start Date :||November 16, 2017|
|Estimated Primary Completion Date :||July 15, 2018|
|Estimated Study Completion Date :||December 15, 2018|
Placebo Comparator: Standard
This study arm utilizes a standard lighting condition in the patient room
Standard lighting is non-dynamical light corresponding to standard hospital lighting.
This study arm utilizes a dynamic lighting from special designed lightfixtures in the ceiling and window sill.
Device: Dynamic light
Dynamic lighting is light that changes in intensity and spectral distribution during the day
- Difference in numbers of drop out in the two groups [ Time Frame: Week 4 ]Number of patients in the two groups that drop out due to the standard or experimental lighting condition
- Visual comfort questionaire [ Time Frame: Week 4 ]Difference in scores in the Visual comfort questionaire
- Change of depression level from baseline to endpoint [ Time Frame: Change scores from baseline to week 4 ]Difference in change scores on the Hamilton Depression Rating scale 17 item from baseline to week 4 in the two groups
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363529
|Contact: Klaus Martiny, DMSc, PhDfirstname.lastname@example.org|
|Contact: Signe Dunker Svendsen, Nurseemail@example.com|
|Mental Health Centre Copenhagen||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Klaus Martiny, DMsc 0045-38647100 firstname.lastname@example.org|
|Principal Investigator:||Klaus Martiny, DMSc, PhD||Mental Health Centre Copenhagen|