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Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this clinical trial is to learn if Auricular acupuncture works to treat Insomnia Post-stroke patients. It will also learn about the safety of Auricular. The main questions it aims to answer are:

  • Does Auricular acupuncture reduce the time it took participants to fall asleep?
  • Dose Auricular acupuncture increase the number of hours participants slept?
  • Dose Auricular acupuncture improve sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)?
  • What medical problems do participants have when taking Auricular acupuncture? Researchers will compare Auricular acupuncture to a sham Auricular acupuncture (a look-alike acupuncture needles that contains no needles) to see if Auricular acupuncture works to treat insomnia post-stroke.

Participants will:

  • Take Auricular acupuncture or sham Auricular acupuncture every 5 days for 4 weeks.
  • Checkups and evaluate sleep onset time, sleep hours, and sleep quality every 5 days for 4 weeks.
  • Keep a diary sleep of their symptoms and the number of times they use sleeping pills.

Eligibility

Inclusion Criteria:

  • Patients aged 18 years or older, with a post-stroke period of 03 months or more, based on discharge papers or medical records.
  • Patients who meet the diagnostic criteria for insomnia according to the DSM-V of the American Psychiatric Association for at least 3 months.

Exclusion Criteria:

  • Patients with insomnia before the stroke.
  • Patients diagnosed with other sleep disorders such as sleep apnea syndrome, narcolepsy.
  • Patients diagnosed with neurological diseases or psychiatric disorders such as: Anxiety disorders, autism spectrum disorders, depression, obsessive-compulsive disorder, behavioral disorders affecting sleep before the stroke.
  • Patients are using antidepressants, psychiatric drugs.
  • Patients participating in other clinical trials with behavioral, psychological or complementary medical interventions during the study period.
  • Patients not cooperating during data collection

Study details
    Insomnia
    Secondary
    Post-stroke Depression

NCT06540664

University of Medicine and Pharmacy at Ho Chi Minh City

14 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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