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

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

Interventions

DEVICE

Dynamic light

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

DEVICE

Standard

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

Sponsors & Collaborators

• Department of Photonics Engineering

  collaborator UNKNOWN

• Chromaviso A/S

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• University Hospital Bispebjerg and Frederiksberg

  lead OTHER

Principal Investigators

• Klaus Martiny, DMSc, PhD · Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-16

Primary Completion

2018-12-19

Completion

2019-03-19

Countries

• Denmark

Study Locations