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

NCT03363529 | Completed DMC

• 1 other identifier: ROOMLIGHT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Light; Therapy, Complications; Sleep Disorders, Circadian Rhythm

Keywords

Dynamic lighting, ipRGC

Outcome Measures

Primary Outcomes (1)

• Difference in numbers of drop out in the two groups

  Number of patients in the two groups that drop out due to the standard or experimental lighting condition

  Week 4

Secondary Outcomes (2)

• Visual comfort questionaire

  Week 4

• Change of depression level from baseline to endpoint

  Change scores from baseline to week 4

Study Arms (2)

Standard

PLACEBO COMPARATOR

This study arm utilizes a standard lighting condition in the patient room

Device: Standard

Dynamic

EXPERIMENTAL

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

Device: Dynamic light

Interventions

Dynamic light DEVICE

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

Dynamic

Standard DEVICE

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

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Chromaviso A/S: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Department of Photonics Engineering: collaborator

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, Denmark, 2100, Denmark

Location

Related Publications (1)

• Volf C, Aggestrup AS, Svendsen SD, Hansen TS, Petersen PM, Dam-Hansen C, Knorr U, Petersen EE, Engstrom J, Hageman I, Jakobsen JC, Martiny K. Dynamic LED light versus static LED light for depressed inpatients: results from a randomized feasibility trial. Pilot Feasibility Stud. 2020 Jan 15;6:5. doi: 10.1186/s40814-019-0548-9. eCollection 2020.

  PMID: 31956421 DERIVED

MeSH Terms

Conditions

Depression; Sleep Disorders, Circadian Rhythm

Interventions

Dynamic Light Scattering; Reference Standards

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Scattering, Radiation; Chemistry Techniques, Analytical; Investigative Techniques; Weights and Measures

Study Officials

• Klaus Martiny, DMSc, PhD

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Hamilton depression interview is done by external assessor blinded to condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Model Details: Standard versus dynamic lighting

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 6, 2017
• Study Start: November 16, 2017
• Primary Completion: December 19, 2018
• Study Completion: March 19, 2019
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)