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

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…

ClinicalTrials.gov IDNCT06540664
PhaseNA
Enrollment60
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
Age18 Years
SexALL
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Conditions studied

Insomnia, Secondary, Post-stroke Depression

About this study

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.

Interventions

Primary outcomes

Eligibility information

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 locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.