Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular Acupuncture needles, Sham Auricular Acupuncture needles.
- Who it may be relevant to
- Registry conditions: Insomnia, Secondary, Post-stroke Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke: A Randomized Controlled Trial
Overview
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
- Other Auricular Acupuncture needles
Auricular Acupuncture needles 5 days in 2 weeks - Other Sham Auricular Acupuncture needles
Sham Auricular Acupuncture needles 5 days in 2 weeks
Primary outcome measures
- Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and Week 4]
Secondary outcome measures (2)
- Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and Week 4]
- Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and Week 4]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Vietnam · 1 center
- HoChiMinh University of Medicine and Phamacy — Ho Chi Minh City
Identifiers
NCT: NCT06540664 · 1100/HDDD-DHYD