Key Finding
This ongoing trial is evaluating whether shallow needling combined with eszopiclone improves sleep quality more effectively than eszopiclone alone in adults with chronic primary insomnia, with results expected in January 2026.
Researchers in China are studying whether a gentle form of acupuncture called "shallow needling" can help adults with chronic insomnia sleep better. Chronic primary insomnia means having ongoing trouble falling asleep or staying asleep for no clear medical reason, which can affect your health, mood, and even increase accident risks. This study involves 124 people with insomnia who will be divided into two groups. The control group will take a common sleep medication called eszopiclone (1 mg daily) for four weeks. The treatment group will receive the same medication plus shallow needling acupuncture five times per week for four weeks. Researchers will measure sleep quality using standard questionnaires, anxiety levels, blood tests for brain chemicals like melatonin and dopamine, and brain imaging of a region called the thalamus that helps control sleep. They'll check results before treatment, right after the four-week treatment period, and again four weeks later to see if improvements last. The study began enrolling patients in August 2023 and final results are expected in January 2026. This research aims to determine whether combining shallow needling with medication works better than medication alone for chronic insomnia, and whether it's safe. If successful, this could provide people with insomnia an additional evidence-based treatment option. If you're considering acupuncture for sleep problems, seek a licensed acupuncturist with appropriate credentials in your state or country.
This single-center, assessor-blinded RCT (ITMCTR2024000409) evaluates shallow needling efficacy for chronic primary insomnia in adults. The study randomizes 124 participants into two parallel arms (n=62 each): control receiving eszopiclone 1 mg daily for 4 weeks, and treatment receiving eszopiclone plus shallow needling (5 sessions weekly for 4 weeks). Primary outcome: Pittsburgh Sleep Quality Index. Secondary outcomes include Hamilton Anxiety Scale, Insomnia Severity Index, serum neurotransmitters (dopamine, norepinephrine, melatonin), polysomnography parameters, and thalamic magnetic resonance spectroscopy. Data collection occurs at baseline, post-treatment, and 4-week follow-up. The study commenced August 2023 with publication anticipated January 2026. This protocol aims to establish evidence-based clinical guidelines for shallow needling as adjunctive therapy in chronic insomnia management. The inclusion of objective biomarkers and neuroimaging represents a methodologically rigorous approach to investigating acupuncture's mechanism of action in sleep disorders.
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