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CompletedNCT03363529ROOM-LIGHTUpdated Feb 25, 2026

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

An interventional study of Dynamic light and Standard in Depression, Light; Therapy, Complications and Sleep Disorders, Circadian Rhythm, sponsored by University Hospital Bispebjerg and Frederiksberg. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by University Hospital Bispebjerg and Frederiksberg · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 124 studies in Depression with a site in Denmark — 14 open to participants now, 17 under way, none of them phase 3. Depression · Denmark.

Enrollment
89th of 92
15 · median 139
Started
2017
with 8 others
No phase
69 of 124
9 open now
Registered
70th of 124
by date
Lead sponsor
4 of 124
University Hospital Bispebjerg and Frederiksberg

Among the 124 studies in Depression with a site in Denmark, this one is the 89th largest by enrollment of the 92 interventional ones that give a count, is one of 9 that started in 2017, is one of 69 with no phase, and was the 70th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

14 of the 124 studies in Depression with a site in Denmark are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 124 studies in Depression with a site in Denmark, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

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

Keywords

  • Dynamic lighting, ipRGC
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe suicidality
  • Actual psychotic state
  • Bipolar disorder
  • Patient is subject to coercive measures of any kind.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Placebo comparator
    Standard

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

    Device: Standard

  • Experimental
    Dynamic

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

    Device: Dynamic light

Interventions

  • DeviceDynamic light

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

  • DeviceStandard

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

06

What researchers measure

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

    Time frame: Week 4

Secondary outcomes

  1. Visual comfort questionaire

    Difference in scores in the Visual comfort questionaire

    Time frame: Week 4

  2. Change of depression level from baseline to endpoint

    Difference in change scores on the Hamilton Depression Rating scale 17 item from baseline to week 4 in the two groups

    Time frame: Change scores from baseline to week 4

07

Study locations

1 site
  • Mental Health Centre Copenhagen
    Copenhagen, Denmark 2100, Denmark
08

References and documents

Publications

  • 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. PubMed 31956421 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Dec 2018, 13 months.

Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 13 months is below that.

Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2017
First posted
Dec 6, 2017
StartActual
Nov 16, 2017
Primary completionActual
Dec 19, 2018
CompletionActual
Mar 19, 2019
Last update
Feb 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03363529
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Collaborators
Department of Photonics Engineering, Chromaviso A/S, Copenhagen Trial Unit, Center for Clinical Intervention Research
Responsible party
Klaus Martiny (Professor of Clinical Psychiatry, University Hospital Bispebjerg and Frederiksberg) — Principal investigator
First posted
Dec 6, 2017
Start date
Nov 16, 2017
Primary completion
Dec 19, 2018
Completion
Mar 19, 2019
Last update
Feb 25, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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