NCT06540664招募中不适用
Evaluating Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke: A Randomized Controlled Trial
University of Medicine and Pharmacy at Ho Chi Minh City1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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)
次要结局
- Change number of hours slept as measured by The Pittsburgh Sleep Quality Index (PSQI)(Baseline and Week 4)
- Change the time it took participants to fall asleep as measured by The Pittsburgh Sleep Quality Index (PSQI)(Baseline and Week 4)
研究者
NGUYEN THI THUY AN
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City
研究点 (1)
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