Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke
NCT ID: NCT06540664
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-03-01
2024-10-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Auricular Acupuncture
Participants received Auricular Acupuncture every 5 days for 2 weeks combined with sleep hygiene, then stopped acupuncture and monitored for effectiveness after 4 weeks.
Auricular Acupuncture needles
Auricular Acupuncture needles 5 days in 2 weeks
Sham Auricular Acupuncture
Participants received sham Auricular Acupuncture every 5 days for 2 weeks combined with sleep hygiene, then stopped acupuncture and monitored for effectiveness after 4 weeks.
Sham Auricular Acupuncture needles
Sham Auricular Acupuncture needles 5 days in 2 weeks
Interventions
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Auricular Acupuncture needles
Auricular Acupuncture needles 5 days in 2 weeks
Sham Auricular Acupuncture needles
Sham Auricular Acupuncture needles 5 days in 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Responsible Party
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NGUYEN THI THUY AN
Principal Investigator
Locations
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HoChiMinh University of Medicine and Phamacy
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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1100/HDDD-DHYD
Identifier Type: -
Identifier Source: org_study_id
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