NCT04812418已完成不适用
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Sleep disorder severity
研究概览
简要总结
The objective of this double-blind randomized clinical trial is to compare the effects of a dietary supplement based on eschscholtzia and valerian extracts to a placebo after 28 days of supplementation, in subjects suffering from sleep troubles associated with anxiety.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Woman or man, aged of 18 to 65 years;
- •In good general health as evidenced by medical history and physical examination;
- •Having at least 3 episodes of sleep disorders per week including one or more of the following:
- •difficulty falling asleep or
- •difficulty staying asleep or
- •poor quality sleep
- •Waking up earlier than desired
- •The insufficient sleep duration and quality is coupled with a feeling of general fatigue;
- •Sleep disorder last for more than 1 month;
- •Presenting moderate to severe sleep disorder in the past month (ISI ≥ 15);
- •With anxiety resulting in a HAM-A score > 8 and < 25;
- •For women of childbearing age (women of childbearing potential, pre-menopausal or having postmenopausal amenorrhea of less than 12 months, and women who have not undergone surgical sterilization):
- •Negative blood pregnancy test
- •Acceptance to use an effective method of contraception, established for at least 1 month, and throughout the duration of the study;
- •Fluent French speaking;
- •Provision of signed and dated informed consent form;
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •A score > 10 on the ESS scale (that would correspond to serious hypersomnia);
- •Sleep disorders secondary to another health problem (sleep apnea syndrome, narcolepsy-cataplexy, idiopathic hypersomnia, restless legs syndrome, chronic pain syndrome, ...) or an environmental factor (noise, light ...) or socio-professional (shift work, young child at home, people who are often jet lagged,... );
- •Severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia,...) or a severe neurologic trouble (Alzheimer's, autism, Parkinson's disease, ...);
- •Subjects presenting severe gastro-intestinal, hepatic, respiratory, kidney or cardiovascular disorder or severe infection (e.g. HIV, hepatitis, ...);
- •Acute or chronic somatic pathologies which can interfere with sleep: kidney cancer, etc.;
- •Subjects with pre-menstrual syndrome or myasthenia gravis;
- •Subjects who drink more than 2 glasses of alcohol per day (> 20g of alcohol per day) or with exaggerated consumption of theine (≥ 1l per day) and caffeine-rich (≥ 800ml per day) beverages and energy drink (≥ 330ml per day);
- •Subject consuming drugs and/or with historical drug addiction;
- •Under psychotropic treatment within the last month before screening (neuroleptic, anxiolytic, antidepressant, hypnotic, sedative, ...) or under current medication treatment which may alter the waking state (for example: cortisone, dopamine, amphetamine, antihistamines, beta-blockers, certain cough syrups, ....);
- •Volunteer with suicidal risk according to the investigator;
- •Under phytotherapy treatment or food supplement for sleep disorders within the last month before screening;
- •Volunteer presenting current infection and/or fever;
- •Volunteer with medical history of stroke or head trauma;
- •Pregnant or lactating woman;
- •Known allergy or intolerance to one product component (valerian, eschscholtzia or excipients);
- •Subjects having participated to another clinical trial (with an investigational product) one month before the inclusion;
- •Subjects that present alterations of their cognitive functions that will interfere with the comprehension of the study and procedures and/or with the completion of questionnaires;
- •Vulnerable patient (deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice, ...);
- •Pharmacological resistance to common hypnotic/sedative drugs;
- •Allergy/intolerance to the actimeter straps;
- •Recent (< 1 month before the inclusion) change in lifestyle (food, body weight > 5kg, sport).
结局指标
主要结局
Sleep disorder severity
时间窗: Baseline and D28 (end of supplementation)
Change from baseline of Insomnia Severity Index (ISI) score
次要结局
- Patient assessment of sleep disorder symptoms improvement after intervention(Baseline and D28 (end of supplementation))
- Short-form 36 questionnaire (SF36)(Baseline and D28 (end of supplementation))
- Anxiety status(Baseline and D28 (end of supplementation))
- Anxiety status over time(Baseline and D49 (end of follow-up))
- Electronic sleep diaries(Baseline, D7, D14, D21 and D28 (end of supplementation))
- Evolution of sleep troubles(Baseline, D28 (end of supplementation) and D49 (end of follow-up))
- Adverse events(Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up))
- Addiction(Baseline and D49 (end of follow-up))
- Sleep disorder severity over time(Baseline and D49 (end of follow-up))
- Investigator assessment of sleep disorder symptoms severity(Baseline and D28 (end of supplementation))
- Investigator assessment of sleep disorder symptoms improvement(Baseline and D28 (end of supplementation))
- Actimeters(Baseline, D7, D14, D21 and D28 (end of supplementation))
研究者
研究点 (2)
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