Clinical trial NCT06540664: Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke
Official title: Evaluating Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia, Secondary
Post-stroke Depression
Keywords: insomnia
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and Week 4
measure: Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: HoChiMinh University of Medicine and Phamacy
Study officials:
References: