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

University of Medicine and Pharmacy at Ho Chi Minh City60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Insomnia, Secondary Post-stroke Depression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 4

Secondary Outcomes

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 4

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 4

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts