Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03363529 |
| Other study ID # |
ROOMLIGHT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2017 |
| Est. completion date |
March 19, 2019 |
Study information
| Verified date |
March 2024 |
| Source |
Mental Health Services in the Capital Region, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
