DRKS00023425已完成未知
To evaluate the tolerability and benefit of Somnum for sleep improvement in healthy subjects with sleep complaints
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 305
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Men and women 40-75 years old
- •2.Moderate sleep complaints within the last year prior to the study, as per investigator’s judgement
- •3.Body mass index (BMI) 18.5–29.9 kg/m2
- •4.Generally in good health as judged by the investigator at the screening visit
- •5.Having access to a smartphone or a computer with an internet access and familiar with the use thereof (checked during the visit)
- •6.Readiness to comply with study procedures, in particular:
- •Consumption of the IP
- •Filling in the subject diary
- •Keeping bedtime habits, usual diet and level of physical exercise, as
- •well as smoking habits (if any)
- •7.Women of childbearing potential:
- •Commitment to use contraception methods
- •Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- •Participation is based upon written informed consent form (ICF) by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
排除标准
- •1.Known sensitivity to any components of the IP
- •2.Insomnia disorder (ICD-11), as per investigator’s judgement
- •3.Insomnia severity index score >10
- •4.Self-reported substantial daily sleepiness (as per investigator's judgement)
- •5.Less than 5 hours sleep per night on average, self-reported
- •6.Self-reported regular daytime sleeping (>1 hour daily)
- •7.Self-reported medical condition associated with sleep complaints, e.g. sleep apnoea, restless legs syndrome, neurological / psychiatric disorder, chronic pain (as per investigator's judgement)
- •8.Lifestyle and other factors potentially associated with sleep problems, e.g. ex-cessive caffeine intake, (night)shift work, long-distance travelling, significant stressors such as active grieving etc. (as per investigator's judgement)
- •9.History and/or presence of clinically significant self-reported disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject:
- •Untreated or non-stabilized diabetes mellitus
- •Untreated or non-stabilized thyroid gland disorder
- •Untreated or non-stabilized hypertension (regular systolic blood
- •pressure =140 mmHg and/or diastolic blood pressure =90 mmHg)
- •Significant gastrointestinal diseases
- •Other known significant or serious condition / disease that renders
- •subjects ineligible (e.g. history of malignancy within the past 5 years
- •prior to study, any clinically significant cardiovascular, renal, liver
- •disease etc.)
- •10.Use of drugs/supplements other than the IP which could interfere with the re-sults of the study as per investigator's judgement (e.g. stimulants, neurolep-tics, benzodiazepines, antidepressants, hypnotics etc.) within the last 4 weeks prior to screening visit and during the study; antihistamines are allowed at a constant dose within the last 4 weeks prior to screening visit and during the study
- •11.History or current abuse of alcohol or drugs
- •12.Women of childbearing potential: pregnancy or nursing
- •13.Participation in another study during the last 4 weeks prior to and during the study
- •14.Any other reason for exclusion as per investigator's judgment, e.g. expected insufficient compliance with study procedures
研究者
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