RecruitingNot ApplicableNCT06540664

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

Evaluating Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke: A Randomized Controlled Trial


Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Enrollment

60 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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

Interventions

OTHERAuricular Acupuncture needles

Auricular Acupuncture needles 5 days in 2 weeks

OTHERSham Auricular Acupuncture needles

Sham Auricular Acupuncture needles 5 days in 2 weeks


Locations(1)

HoChiMinh University of Medicine and Phamacy

Ho Chi Minh City, Vietnam

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NCT06540664


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