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

Last updated: September 26, 2024
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Auricular Acupuncture needles

Sham Auricular Acupuncture needles

Clinical Study ID

NCT06540664
1100/HDDD-DHYD
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

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 theAmerican Psychiatric Association for at least 3 months.

Exclusion

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-compulsivedisorder, behavioral disorders affecting sleep before the stroke.

  • Patients are using antidepressants, psychiatric drugs.

  • Patients participating in other clinical trials with behavioral, psychological orcomplementary medical interventions during the study period.

  • Patients not cooperating during data collection

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Auricular Acupuncture needles
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • HoChiMinh University of Medicine and Phamacy

    Ho Chi Minh City,
    Vietnam

    Active - Recruiting

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