A Randomized, Double-Blind, Placebo-Controlled, 6-Week Decentralised Trial Evaluating the Effects of PeptiSleep on Sleep Quality in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sleep Quality via Leeds Sleep Evaluation Questionnaire
研究概览
简要总结
Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults
详细描述
The primary aim of this is double-blind placebo-controlled parallel-design study is to measure the effects of PeptiSleep on sleep quality in healthy adults. PeptiSleep will be supplemented 30-60 minutes before bed as a single oral dose of 250mg for 6-weeks. A placebo group will also be included who will receive a matched dose of microcrystalline cellulose in identical capsules.
This trial incorporates a wearable sleep tracker to measure sleep biometrics which will be worn by participants for the duration of the study, as well as clinically validated questionnaires to measure sleep quality and a digital cognitive battery for to assess next day performance. The trial will be conducted over 6-weeks. 4 weeks of sleep tracking data will serve as a baseline prior to initiation of the supplementation period. The trial is fully decentralised.
The primary endpoint will measure the effects of PeptiSleep supplementation on responsive sleep quality via Leeds Sleep Evaluation Questionnaire versus a placebo from baseline to the end of the study period.
Secondary endpoints investigated during the trial will include changes in sleep biometrics (cardiac measures, sleep architecture, latency etc.) via Oura wearable, changes in comprehensive sleep quantity via Pittsburgh Sleep Quality Index (PSQI), next day readiness and next day performance via Creyos digital testing platform and safety and tolerability via adverse event reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- 是
入选标准
- •Adults aged 18-65 at the time of enrollment.
- •Generally healthy
- •BMI 18.5 - 35.0kg/m2
- •Willing and able to provide informed consent.
- •Willing to consume one PeptiSleep or placebo capsule daily for 6 weeks.
- •Willing to wear a sleep tracker continuously throughout the study period.
- •Willing to complete all scheduled surveys and cognitive assessments on Days 0, 1, 2, and 3, at biweekly check-ins (Week 2 and Week 4), and at End-of-Study (Day 42).
- •Willing to sync their wearable device data through the Reputable Health app and complete daily check-ins for compliance assessment
- •Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.
- •Agree to maintain a stable lifestyle and medication routines for at least 4 weeks prior to enrollment
- •Agree not to use other medicines or supplements for sleep, stress, depression, or anxiety other than the test product during enrolment period.
- •Agree to refrain from participation in another clinical trial during enrolment period.
- •Agree to comply with Creyos digital platform data usage and privacy policy
排除标准
- •Are currently pregnant, breastfeeding, or planning pregnancy during the study period.
- •Are using prescription or over-the-counter sleep medications (e.g., zolpidem, melatonin >5 mg, benzodiazepines, CBD or antihistamines used for sleep, stress, depression, or anxiety within 4-weeks prior to enrolment.
- •Have a current diagnosis of a chronic medical condition or illness (e.g., uncontrolled thyroid disease, diabetes, cardiovascular disease, major depressive disorder, or anxiety disorder requiring ongoing pharmacologic treatment) or a chronic sleep disorder, insomnia, restless leg syndrome, sleep apnoea.
- •Are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 4-weeks and any other sleep clinical trial during the past 3 months.
- •Have a known allergy or sensitivity to any component of the investigational or placebo product
- •Are shift workers or have highly irregular sleep/wake schedules that could confound study outcomes.
- •Are unable or unwilling to comply with daily product use, wearable requirements, or survey/assessment completion.
- •Have with significant non-wear time of their Oura device exceeding a 48- hour period
- •Are using medications which induce CYP3A4 such as phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids.
- •Are using prescription or OTC medications or supplements for sleep, stress, depression, or anxiety including CBD within one month prior to enrolment.
- •Are using aromatherapy to help manage sleep, stress, depression, or anxiety within 4-weeks prior to enrolment.
- •Are using a digital device (besides Oura) to help monitor or manage sleep during the study period.
- •Have a current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
- •Have been diagnosed with or have consistent gastrointestinal issues that disrupt sleep.
- •Have a history of renal function impairment
- •Have with COPD or a chronic breathing disorder
- •Are active smokers, nicotine use or drug (prescription or illegal substances) abuse.
- •Have a chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Are regularly taking stimulants (e.g., coffee, caffeine supplements, beverages containing caffeine) 5 hours before bed
- •Are regularly consuming more than 500mg of caffeine per day
- •Have any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
研究组 & 干预措施
PeptiSleep 250 mg/day
One capsule to be consumed orally 30-60 minutes before bed
干预措施: PeptiSleep (Dietary Supplement)
Microcrystalline Cellulose 250 mg/day
One capsule to be consumed orally 30-60 minutes before bed
干预措施: Micro-crystalline cellulose (Dietary Supplement)
结局指标
主要结局
Sleep Quality via Leeds Sleep Evaluation Questionnaire
时间窗: Day 0 to Day 42
Change from baseline to the end of the study period in Sleep Quality via Leeds Sleep Evaluation Questionnaire (LSEQ). The LSEQ comprises ten self-rating 100-mm-line analogue questions concerned with aspects of sleep and early morning behaviour. A visual analogue scale is used with two extreme states defined at the ends of the line (e. g. Tired = score of 0, Alert = score of 10). The subject responds by placing a vertical mark on the line to indicate his present self- evaluation. The four subscales are as follows: * The ease of getting to sleep (GTS), questions 1-3 * The perceived quality of sleep (QOS), questions 4-5 * The easy of awakening from sleep (AFS), questions 6-7 * The integrity of behaviour following wakefulness (BFW), questions, 8-10
次要结局
- Sleep Quality via Pittsburgh Sleep Quality Index(Day 0 to Day 42)
- Heart Rate Variability via Wearable Technology(Day 0 to Day 42)
- Nocturnal Heart Rate via Wearable Technology(Day 0 to Day 42)
- Sleep Onset Latency via Wearable Technology(Day 0 to Day 42)
- Sleep Architecture via Wearable Technology(Day 0 to Day 42)
- Sleep Summary Metrics via Wearable Technology(Day 0 to Day 42)
- Safety and Tolerability via Adverse Event Reporting(Day 0 to Day 42)
- Feature Match Attention Test(Day 0 to Day 42)
- Double Trouble Accuracy Test(Day 0 to Day 42)
- Token Search Memory Test(Day 0 to Day 42)
- Visuospatial Reasoning via Number Ladder Test(Day 0 to Day 42)
- Verbal Short Term Memory via Digit Span Test(Day 0 to Day 42)