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ROOM-LIGHT: Dynamic LED-light as Treatment for Depressed Patients in Inpatient Wards (ROOM-LIGHT)

This study is currently recruiting participants.
Verified December 2017 by Mental Health Centre Copenhagen
Sponsor:
ClinicalTrials.gov Identifier:
NCT03363529
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
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.
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Chromaviso
Department of Photonics Engineering
Information provided by (Responsible Party):
Mental Health Centre Copenhagen
  Purpose

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 Intervention
Depression Light; Therapy, Complications Sleep Disorders, Circadian Rhythm Device: Dynamic light Device: Standard

Study Type: Interventional
Study Design: 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

Further study details as provided by Mental Health Centre Copenhagen:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 15
Actual Study Start Date: November 16, 2017
Estimated Study Completion Date: December 15, 2018
Estimated Primary Completion Date: July 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03363529


Contacts
Contact: Klaus Martiny, DMSc, PhD 0045-38647100 klaus.martiny@regionh.dk
Contact: Signe Dunker Svendsen, Nurse 0045-38647102 signe.dunker.svendsen@regionh.dk

Locations
Denmark
Mental Health Centre Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Klaus Martiny, DMsc    0045-38647100    klaus.martiny@regionh.dk   
Sponsors and Collaborators
Mental Health Centre Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Chromaviso
Department of Photonics Engineering
Investigators
Principal Investigator: Klaus Martiny, DMSc, PhD Mental Health Centre Copenhagen
  More Information

Responsible Party: Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT03363529     History of Changes
Other Study ID Numbers: ROOMLIGHT
First Submitted: November 16, 2017
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Sleep Wake Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases