Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Auricular Acupuncture needles
Other interventionAuricular Acupuncture needles 5 days in 2 weeks
Sham Auricular Acupuncture needles
Other interventionSham Auricular Acupuncture needles 5 days in 2 weeks
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Auricular AcupunctureExperimental treatment 1 intervention
Group B: Sham Auricular AcupunctureSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)
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)
Time frame
Baseline and Week 4Secondary outcomes
1
Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI)
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)
Time frame
Baseline and Week 42
Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI)
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)
Time frame
Baseline and Week 4Sponsors and contacts
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Source ClinicalTrials.gov