NCT05815147已完成不适用
An Exploratory Real-world Study to Explore the Effects of Fortified Powdered Beverage on Sleep Quality in Chinese Adults with Mild Sleep Issue(s) or Complaint(s)
Danone Nutricia1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sleep quality
研究概览
简要总结
The goal of this exploratory study is to explore the sleep and related health benefits of the study product in Chinese middle-aged & elderly population in real world settings and potentially generate hypothesis on key exploratory and other exploratory objectives. The main questions it aims to answer are:
- To explore the effects of test product on sleep quality;
- To understand and evaluate effects of test product on sleep pattern;
- To assess the subjects' overall health status self-evaluation. etc.
Participants will be asked to take study product, collect the sleep pattern parameters and report the overall health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults older than 50 years of age;
- •Chinese ethnicity;
- •BMI is between 18 and 30 (excluding upper and lower bound values);
- •Mild sleep issue(s) and/or complaint(s), including but not limited to difficulty initiating sleep, difficulty maintaining sleep, increased number of nocturnal awakenings, early awakening, complaints of non-restorative sleep, dissatisfaction with sleep quality etc.;
- •PSQI score >7 at screening;
- •PHQ-4 score ≤ 3 at screening;
- •Sufficient ability in Chinese to complete informed consent and other study documents, and willingness to complete this study according to the study protocol;
- •Sufficient ability to install and use a secure WeChat platform on the mobile phone during the study period; stable connectivity to network through mobile phone;
- •Sufficient reading and writing and understanding ability in Chinese to complete questionnaires; daily diaries etc.;
- •Can be directly contacted by mobile phone or WeChat throughout the study;
- •Stable life status with no cross-provincial moving or job changing in the past 6 months, no intention to move or change job during study period.
排除标准
- •Currently receiving medication and other therapies for sleep disorders, including but not limited to sleeping pills and traditional Chinese medicine or therapies;
- •Predominant complaint(s) of parasomnia or sleep apnea and/or medically diagnosed primary sleep disorders including but not limited to obstructive sleep apnea (OSA), narcolepsy, periodic limb movement (PLMD), restless leg syndrome (RLS), or REM sleep behaviors disorder;
- •Long-term (≥3 months) use of drugs that induce sleep disturbances, including but not limited to CNS stimulants, anti-depressents, antipsychotics etc.;
- •Use sedative drugs within 4 weeks prior to screening;
- •Use of dietary supplements with sleep effects within 4 weeks prior to screening including but not limited to melatonin, GABA, Ziziphi Spinosa Semen etc.;
- •Average daily caffeinated drinks intake of 5 cups or more (200ml/cup) , including but not limited to coffee, tea, energy drinks, during 4 weeks prior to screening, or during the study period;
- •Allergic or intolerant to the ingredients of the investigational products, such as protein allergy, dairy allergy, lactose intolerance, soy allergy and fish allergy etc. ;
- •The presence of drug abuse or alcohol and/or psychoactive substances abuse;
- •Those who work night shifts or perform unusal working hours;
- •The presence of medical, psychological or social conditions that may interfere with the subject's participation in the study or affect the evaluation of the study results at the investigator's discretion;
- •Pregnant and lactating women, caregivers of newborns unsuitable for trial participation at the investigators' discretion;
- •Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to enrolment;
- •Do not agree to sign the informed consent.
结局指标
主要结局
Sleep quality
时间窗: 6 weeks
Sleep quality is measured by Chinese version Pittsburgh Sleep Quality Score (CPSQI). The total score ranges from 0 to 21 points. The higher score indicates the worse sleep quality.
次要结局
未报告次要终点
研究者
研究点 (1)
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