NCT06540664 Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke
| NCT ID | NCT06540664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Medicine and Pharmacy at Ho Chi Minh City |
| Condition | Insomnia, Secondary |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2024-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-03-01 with a primary completion date of 2024-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06540664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia, Secondary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06540664 currently recruiting?
Yes, NCT06540664 is actively recruiting participants. Contact the research team at nguyenan27011997@gmail.com for enrollment information.
Where is the NCT06540664 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06540664 clinical trial?
NCT06540664 is sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. The trial plans to enroll 60 participants.
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