Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT07258433
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07258433
Study Brief:
Protocol Section:
NCT07258433