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Light at the end of the tunnel? wearable device aims to lift elderly depression

NCT ID NCT07232472

Symptom relief Sponsor: China Medical University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tests whether a wearable headband that shines near-infrared light can improve depression and sleep in adults aged 60 and older with major depression. Participants will wear the device for up to 8 weeks, and researchers will track sleep, mood, and daily activity using a separate wrist monitor. The study also builds a long-term database to better understand and predict depression in older adults.

What this could mean

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

Active substance
near-infrared photobiomodulation wearable headband
What this could lead to
If it works, this could offer a safe, drug-free way to improve mood and sleep in older adults with depression.
What could go wrong
This is an early-stage study with only 162 participants. The sham device may produce similar effects, and results may not apply to everyone.

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 162 people

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

Started

Apr 2026

Expected to finish

Dec 2029

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

60 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: 1. Subjects must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), either single or recurrent episode. 2. Have a Hamilton Depression Rating Scale (HAM-D, 17-item) total score of 14 or higher at baseline. 3. Participants who are currently taking medications that may affect mood, sleep, or circadian rhythms (e.g., antidepressants, sedative antipsychotics, or sleep aids) may be included, provided that the dosage has remained stable for at least two weeks prior to enrollment. 4. Prior to inclusion, informed consent must be obtained. If cognitive impairment prevents subjects from signing, consent may be obtained from their primary caregiver (who may be a legal or professional representative). Exclusion Criteria: 1. Diagnosis of dementia of any severity, bipolar disorder, psychotic disorder, psychotic episode, or substance use disorder. 2. Active suicidal ideation or suicide attempt within the past three months. 3. Any other conditions deemed unsuitable for participation by the clinical physician, such as: * Currently experiencing acute delirium. * Suffering from respiratory infections, including COVID-19. 4. Participants with significant skin conditions on the head or conditions that could affect the efficacy of light therapy will be excluded. These include cases with: * Hemangiomas. * Scleroderma. * Psoriasis. * Rashes. * Open wounds. * Tattoos on the head. Additionally, individuals with head implants or those who have undergone photosensitizing drug treatments within two weeks prior to trial participation will also be excluded.

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Conditions

The condition(s) this trial relates to.

depressive disorder major depressive disorder Parasomnias sleep disorder

As listed by the trial registrant

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

Elderly depression Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • China Medical University Beigang Hospital

    London, Alabama, WC1N 2AN, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.