Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06540664

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

Led by University of Medicine and Pharmacy at Ho Chi Minh City · Updated on 2024-10-01

60

Participants Needed

1

Research Sites

30 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older with a post-stroke period of 3 months or more based on discharge papers or medical records
  • Patients who meet the diagnostic criteria for insomnia according to the DSM-V for at least 3 months
Not Eligible

You will not qualify if you...

  • Patients with insomnia before the stroke
  • Patients diagnosed with other sleep disorders such as sleep apnea syndrome or narcolepsy
  • Patients diagnosed with neurological or psychiatric disorders such as anxiety disorders, autism spectrum disorders, depression, obsessive-compulsive disorder, or behavioral disorders affecting sleep before the stroke
  • Patients using antidepressants or 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

HoChiMinh University of Medicine and Phamacy

Ho Chi Minh City, Vietnam

Actively Recruiting

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Research Team

A

An Thi Thuy Nguyen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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