Insomnia, Secondary, Post-stroke Depression
Conditions
Keywords
insomnia
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.
Interventions
OTHERSham Auricular Acupuncture needles
Sham Auricular Acupuncture needles 5 days in 2 weeks
OTHERAuricular Acupuncture needles
Auricular Acupuncture needles 5 days in 2 weeks
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI) | Baseline and Week 4 | The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. Possible scores range from 0 to 21. PSQI \< 5 (good sleep quality), PSQI \>5 (poor sleep quality) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI) | Baseline and Week 4 | The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. The score of hours slept range 0 (hours of sleep \> 7 hours) to 3 (Hours of sleep \< 4 hours) |
| Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI) | Baseline and Week 4 | The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported instrument assessing sleep quality over 1 month. The score of time it took participants to fall asleep range 0 (\<15 minutes) to 3 ( \>60 minutes) |
Countries
Vietnam
Contacts
Primary ContactAn Thi Thuy Nguyen
Outcome results
None listed