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

ID: NCT03363529
Status: Recruiting
Phase: N/A
Start Date: November 16, 2017
First Submitted: November 16, 2017
Last Updated: December 05, 2017
Results: N/A
Sponsors & Collaborators: Mental Health Centre Copenhagen, Copenhagen Trial Unit, Center for Clinical Intervention Research, Chromaviso, Department of Photonics Engineering
Location: Denmark
Conditions: Depression, Light; Therapy, Complications, Sleep Disorders, Circadian Rhythm
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Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Depression

Light; Therapy, Complications

Sleep Disorders, Circadian Rhythm

Device: Dynamic light
Other Names
Device: Standard
Other Names
N/A

Tracking Information

First Submitted DateNovember 16, 2017
Last Update Posted DateDecember 05, 2017
Actual Start DateNovember 16, 2017
Anticipated Completion DateDecember 15, 2018
Actual Primary Completion DateJuly 15, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current 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

Original Primary Outcome Measures

Not Available

Current 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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleROOM-LIGHT: Dynamic LED-light as Treatment for Depressed Patients in Inpatient Wards
Official TitleROOM-LIGHT: Dynamic LED-light as Treatment for Depressed Patients in Inpatient Wards: A Feasibility Trial
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.

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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
15
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Depression
Light; Therapy, Complications
Sleep Disorders, Circadian Rhythm
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Device: Dynamic light

Dynamic lighting is light that changes in intensity and spectral distribution during the day

Other Names
Device: Standard

Standard lighting is non-dynamical light corresponding to standard hospital lighting.

Other Names
Study Groups/Cohorts
Standard
This study arm utilizes a standard lighting condition in the patient room

Dynamic
This study arm utilizes a dynamic lighting from special designed lightfixtures in the ceiling and window sill.

Study Arms
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

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.

Arm Intervention/Treatment
Experimental Dynamic
This study arm utilizes a dynamic lighting from special designed lightfixtures in the ceiling and window sill.
Device : Dynamic light
Placebo Comparator Standard
This study arm utilizes a standard lighting condition in the patient room
Device : Standard

Recruitment Information

Recruitment Status:Recruiting
Enrollment15
Completion DateDecember 15, 2018
Eligibility 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Denmark

Administrative Information

NCT Number:NCT03363529
Other Study ID Numbers
ROOMLIGHT
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Mental Health Centre Copenhagen
Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research
Chromaviso
Department of Photonics Engineering
Investigators
Principal Investigator
Klaus Martiny, DMSc, PhD
Mental Health Centre Copenhagen