Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aventure AB
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Sleep onset latency
研究概览
简要总结
The overall purpose of this interventional study is to investigate how a specific herbal extract influences the quality of sleep in middle-aged women with mild to moderate insomnia. During the study, the participants are asked to take the test drink every night for two weeks. Both objective (Oura ring) and subjective (analog sleep diaries, questionnaires) measures are included to evaluate sleep parameters as well as perceived alertness and impact on daily functions. The primary outcome is sleep onset latency (SOL), which is the time it takes for a person to fall asleep. Secondary outcomes which will be evaluated include time spent in different sleep stages, number of times waking up during the night, and various qualitative ratings of energy levels and mood during the day.
Researchers will compare the group with active product and placebo product to see if the consumption of the herbal extract will lead to improvements in the factors mentioned above.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A copy of the randomization list will be provided to those packing the product kits. The randomization list is a document that consists of randomization numbers, which uniquely assign each study patient to one of the treatments. The sponsor and all staff directly involved in the trial will thus be blinded to the product allocated to the participants. The randomization number will be documented.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 35-60
- •BMI 18-30 kg/m2
- •Mild to moderate insomnia according to the ISI (Insomnia Severity Index) questionnaire (ISI-value 10-21)
- •Matching results from the Oura ring and sleep diaries during the run-in period
排除标准
- •Metabolic disease (diabetes, cardiovascular disorders, hypo- or hyperthyroidism, etc)
- •Severe psychiatric disorders
- •Pregnancy, breastfeeding
- •Restless legs or leg cramps that influence sleep and everyday life
- •Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc)
- •Breathing problems (asthma, severe snoring, sleep apnea, etc)
- •Medication that can influence sleep and/or wakefulness
- •Consumption of herbal sedatives during the last month
- •Having someone in the household that needs to be tended to during the night and pose a major risk to disturb the research participant's sleep to a large extent.
- •Irregular work hours, including shift work at night
- •Regularly sleeping more than 1 night per week away from home
- •Tobacco or drug use
- •Other factors that are deemed to influence participation negatively
研究组 & 干预措施
Active product
The active product is a drink consisting of 600 mg of lemon balm extract, tea leaves, brown sugar and powdered flavoring agent that is mixed with lukewarm water. The volume per serving is 30 ml. The drink will be taken every night before sleep for a period of two weeks.
干预措施: Herbal extract drink (Other)
Placebo
The placebo drink is maltodextrin mixed with water, and the same tea leaves, brown sugar and powdered flavoring agent as the test drink. The volume per serving is 30 ml. The drink will be taken every night before sleep for a period of two weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Sleep onset latency
时间窗: 2 weeks
The length of time it takes a person to fall asleep when turning the lights off, this parameter will be measured by using the Oura Ring
次要结局
- Perceived alertness and wellbeing during the day(2 weeks)
- Time spent in different sleep stages(2 weeks)