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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. Read our disclaimer for details. Identifier: NCT03363529
Recruitment Status : Unknown
Verified December 2017 by Mental Health Centre Copenhagen.
Recruitment status was:  Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Copenhagen Trial Unit, Center for Clinical Intervention Research
Chromaviso A/S
Department of Photonics Engineering
Information provided by (Responsible Party):
Mental Health Centre Copenhagen

Brief Summary:

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

Detailed Description:

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.

Primary outcome:

1. Rate of patients discontinuing the trial due to discomfort from the lighting condition.

Secondary outcomes:

  1. Mean scores on the visual comfort scale in the intervention period
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Standard
This study arm utilizes a standard lighting condition in the patient room
Device: Standard
Standard lighting is non-dynamical light corresponding to standard hospital lighting.

Experimental: Dynamic
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Visual comfort questionaire [ Time Frame: Week 4 ]
    Difference in scores in the Visual comfort questionaire

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Major depression disorder
  • Age > 18 years
  • Informed consent and Danish speaking.

Exclusion Criteria:

  • Severe suicidality
  • Actual psychotic state
  • Bipolar disorder
  • Patient is subject to coercive measures of any kind.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03363529

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Contact: Klaus Martiny, DMSc, PhD 0045-38647100
Contact: Signe Dunker Svendsen, Nurse 0045-38647102

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Mental Health Centre Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Klaus Martiny, DMsc    0045-38647100   
Sponsors and Collaborators
Mental Health Centre Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Chromaviso A/S
Department of Photonics Engineering
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Principal Investigator: Klaus Martiny, DMSc, PhD Mental Health Centre Copenhagen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mental Health Centre Copenhagen Identifier: NCT03363529    
Other Study ID Numbers: ROOMLIGHT
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mental Health Centre Copenhagen:
Dynamic lighting, ipRGC
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Chronobiology Disorders
Occupational Diseases