Laser acupuncture may ease sleeplessness in depression
NCT ID NCT06443242
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
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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
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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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.
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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.
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