Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Enrolling

Conditions: Post-stroke Depression; Insomnia, Secondary

Treatments: Other: Auricular Acupuncture needles; Other: Sham Auricular Acupuncture needles

Study type: Interventional

Funder types: Other

Identifiers

NCT06540664

1100/HDDD-DHYD

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Auricular Acupuncture

Experimental group

Description:

Participants received Auricular Acupuncture every 5 days for 2 weeks combined with sleep hygiene, then stopped acupuncture and monitored for effectiveness after 4 weeks.

Treatment:

Other: Auricular Acupuncture needles

Sham Auricular Acupuncture

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Auricular Acupuncture needles