The Sleep Well Observation Study: a Single-arm, Open-label, Prospective Intra-individual Change Controlled, Exploratory Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- A. Vogel AG
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in perceived sleep quantity/quality
研究概览
简要总结
Insomnia is characterized by the recurring difficulty to fall or remain asleep despite motivation and means to do so. People with insomnia also experience excessive daytime sleepiness and other cognitive impairments while they are awake. Facing the situation mentioned and realizing that especially early preventive measures are needed to fight the increasing costs for treatment of sleep related diseases, effective nutrients might be a good and safe option to improve sleep quality.This single-arm, open-label, prospective, observational exploratory pilot study aims at collecting first data on efficacy and safety of "Sleep Well".
详细描述
This single-center study is a one-armed, open-label, prospective, observational exploratory pilot study and has a duration of 17 days per participant. A total of 50 healthy participants (n=25 female, n=25 male) aged 18-50 years inclusive reported sleep problems at a preliminary stage to the criteria of the German "S3 guideline non-restorative sleep/sleep disorders - insomnia in adults" for the definition of non-organic insomnia according to ICD-10 (F 51.0) are included into the study.
The total study population of N=50 will include two groups: A subgroup of n=40 will not undergo polysomnographic assessment (nonPSG), a group of n=10 will undergo polysomnographic assessment (PSG), in addition to all other assessments. The nonPSG group has a total of 3 study centre visits (V1, V2, V3) and and the PSG group has two further visits prior to V2 and V3 resulting in five study centre visits (V1, V2-1, V2, V3-1, V3). Except for the PSG, all other assessments are identical in the two groups.
All included individuals will take one Sleep Well sachet daily over an intake period of 14 days with an acute dosage at two visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Voluntary, written, informed consent to participate in the study.
- •Male or female aged between 18-50 years (inclusive).
- •Self reported sleep problems precursing the criteria of the German "S3 guideline non-restorative sleep/sleep disorders - insomnia in adults".
- •Habitual bedtime between 9 pm and midnight.
- •Agreement to avoid foods such as pitted fruit, bananas and chocolate 24 hours before saliva sample collection.
- •Willing to download wearable app.
- •Easy access to internet for daily e-diary.
- •Cooling capacities available for storage of saliva samples
排除标准
- •• Body mass index (BMI) <18.0 or >30.0 kg/m
- •Women who are currently pregnant or breastfeeding.
- •Any known history of a disorder affecting sleep quality, such as narcolepsy, obstructive sleep apnea (OSA), restless leg syndrome (RLS), periodic limb movement syndrome (PLMS) or any organic caused sleep disorders e.g. benign prostatic hyperplasia (BPH), renal insufficiency, hepatopathy, urinary tract infections, irritated bladder, or any psychiatric disorder, e.g. depression, anxiety.
- •Have a significant acute or chronic coexisting illness or any condition which contraindicates entry to the study in the opinion of the Investigator (e.g. migraines, active infections).
- •Previous (last 4 weeks prior to screening) or current intake of drugs that could influence sleep patterns including hormone therapy, health products and oriental herbs.
- •Binge drinking (males >140 g/week, females >70 g/week), heavy smoking (>10 cigarettes/day), high caffeine intake (>10 glasses/day).
- •Self-declared illicit drug use (including cannabis and cocaine) for 3 months prior to screening and during the intervention period.
- •Have a high blood pressure (systolic over 159 mmHg or diastolic over 99 mmHg).
- •Have learning and/or behavioural difficulties such as dyslexia or attention deficit hyperactivity disorder (ADHD).
- •Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness).
- •History or planned travel to a different time zone within 1 month of the first visit or/and during the study participation.
- •Not fluent in German.
- •Have relevant food allergies/intolerances/sensitivities to any substance in the study product.
- •Have oral disease.
- •Participation in another study with any investigational product within 30 days of screening and during the intervention period.
- •Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
结局指标
主要结局
Change in perceived sleep quantity/quality
时间窗: 1 day intervention
Measured as per daily electronic sleep diary entries at home. Comparing pre vs. post intervention assessment.
次要结局
- Change in negative emotional state(2 weeks)
- Tolerability of the investigational product in view of subject(1 day and 2 weeks)
- Change in perceived sleep quantity/quality summarized retrospectively(2 weeks)
- Change in biomarker for chronic stress via CAR(2 weeks)
- Change in PSG-recorded sleep quantity/quality(1 day intervention and 2 weeks)
- Change in physiological sleep quantity/quality(1 day and 2 weeks intervention)
- Change in state anxiety(1 day intervention and 2 weeks)
- Change in quality of life(2 weeks)
- Change in biomarker for chronic stress(2 weeks)
- Change in domain specific cognitive performance(1 day and 2 weeks)
- Change in biomarker for sleep readiness(2 weeks)
- Change in daytime sleepiness(2 weeks)
- Adverse events(1 day and 2 weeks)