Light therapy tested to calm confused ICU patients

NCT ID NCT05807178

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether dynamic light therapy can restore natural sleep-wake cycles in intensive care patients suffering from delirium. Forty adults in the ICU will receive either a special light algorithm or standard hospital lighting. Researchers will measure changes in melatonin, clock genes, and other markers to see if the light helps reset their internal body clocks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dynamic light therapy device
What this could lead to
If it works, this could offer a simple, drug-free way to reduce delirium and improve recovery in ICU patients.
What could go wrong
This is a very small early-stage trial with only 40 participants, so results may not apply broadly. The effect of light on delirium is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit * Male and female patients with age ≥ 18 years * Expected intensive care unit stay ≥ 2 days * Positive delirium during and up to a maximum of 30 days after study inclusion (determined by CAM-ICU, at least once per shift) Exclusion Criteria: * Participation in other clinical studies during the study period and ten days before * Previous ICU treatment during the current hospital stay * Patients with psychiatric diseases * Patients with a history of stroke and known severe residual cognitive deficits * Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay * Amaurosis * History of sleep-related breathing disorders * History or suspicion of hypoxic brain damage * History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion * Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial * The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time * History of photoallergic reactions or history of visually triggered seizures * Severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light * Patients with liver cirrhosis * Patients with a probability of survival \<24h * Optic neuritis within the last 3 months * Travel across two time zones within 3 months prior to study screening * Women who are pregnant, have a positive pregnancy test, are breastfeeding or plan to become pregnant during the course of this clinical trial * Therapy-refractory blood coagulation disorder and inability to consent are exclusion criteria for a muscle biopsy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte

    RECRUITING

    Berlin, 10117, Germany

  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Klinikum

    RECRUITING

    Berlin, 13353, Germany

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