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Laser acupuncture may ease sleeplessness in depression

NCT ID NCT06443242

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 This study
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether low-dose laser acupuncture (LLA) can safely improve sleep in 120 adults with major depressive disorder and insomnia. Participants will receive either real or sham laser acupuncture five times a week for six weeks, while continuing their usual depression medications. Sleep quality, depression severity, and blood markers will be measured before, right after, and 12 weeks after treatment.

What this could mean

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

Active substance
low-dose laser acupuncture (device)
What this could lead to
If it works, this could offer a safe, non-drug option to improve sleep and mood in people with depression.
What could go wrong
This is a small, early-stage trial with no phase. The sham control may also show benefits, and results may not apply to everyone with depression.

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 120 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Aug 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 to 60 years

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. Inpatients with a diagnosis of major depressive disorder (diagnosed according to the relevant diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-V). 2. Male or female, 18 to 60 years of age. 3. Participants complaining of insomnia at initial screening. 4. PSQI score over 7. 5. HAMD score between 20 and 35. 6. No use of hypnotic medication or acupuncture treatment within the last month. 7. No cognitive or communication disorders. 8. Willingness to accept random group assignment and sign an informed consent form. 9. Those who have been on stable dose of antidepressant for at least the most recent two weeks and willing to maintain on the same dosage throughout the study. Exclusion Criteria: 1. Individuals with a marked tendency towards suicide, as assessed by a specialist; 2. Individuals previously diagnosed with schizophrenia, bipolar disorder, or other psychiatric disorders; 3. Individuals with severe alcohol or drug abuse issues; 4. Individuals with liver or kidney dysfunction, or with uncontrollable tumors or significant cerebrovascular diseases; 5. Women who are pregnant or breastfeeding; 6. Individuals likely to have poor compliance or who are fearful of acupuncture treatment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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