The Effect of Alpha-s1 Casein Hydrolysate for Patients With Chronic Insomnia: A Randomized Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
This study investigates the impact of Aalpha-s1 casein hydrolysate (ACH; Lactium®) on sleep quality in individuals with chronic insomnia, employing both subjective sleep profiles and objective polysomnography (PSG) recordings.
详细描述
During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition);
- •PSQI score greater than 5;
- •participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.
排除标准
- •currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks);
- •patients with a history of significant head trauma;
- •individuals with alcohol abuse within the past year;
- •those with other severe medical conditions (e.g., hepatic or renal dysfunction);
- •Pregnant women or breastfeeding mothers;
- •participants unable to comply with the trial schedule;
- •individuals on a vegetarian diet;
- •those with allergies to dairy products.
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 2nd and 4th week
A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.
General Sleep Disturbance Scale (GSDS)
时间窗: 2nd and 4th week
A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).
Insomnia Severity Index (ISI)
时间窗: 2nd and 4th week
A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Hospital Anxiety and Depression Scale (HADS)
时间窗: 2nd and 4th week
A sleep-related questionnaire, ranging from 0 to 21. A total score of \>8 points denotes considerable symptoms of anxiety or depression.
Epworth Sleepiness Scale (ESS)
时间窗: 2nd and 4th week
A sleep-related questionnaire, ranging from 0 to 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.
Sleep quality
时间窗: baseline and 4th week
Polysomnography (PSG)
次要结局
未报告次要终点
研究者
Chun-pai Yang, MD
Chief, Department of Neurology Affiliation: Kuang Tien General Hospital
Kuang Tien General Hospital