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:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT03514732
Eligibility Criteria:
Inclusion criteria :
* Healthy men or women volunteers, aged from 20 to 75 years included at the moment of the inclusion visit.
* Subject with Body Mass Index (BMI) between 18.5 and 29.9 kg/m² (limits included).
* Good general health (based on subject interview about his/her medical history and on clinical exam realized by investigator).
* Subject willing to follow diet recommendations in accordance with hygiene and dietary advice defined in the protocol.
* Subject suffering from mild to moderate sleep disorders assessed by Insomnia Severity Index (ISI) questionnaire completed during the selection and presenting a score between 7 and 22 (limits excluded).
* Subject covered by a social security or insurance.
Exclusion criteria:
* Subject having consumed medications for sleep disorders (sleeping pills) during the 6 months previous the inclusion visit and throughout the study duration.
* Subject having consumed dietary supplements for sleep disorders during the 3 months previous to inclusion visit and throughout the study duration.
* Subject presenting history of severe chronic disease (cancer, HIV, renal or hepatic failure, hepatic disorders, inflammatory digestive and known malabsorption diseases, arthritis or chronic respiratory insufficiency, etc.) found to be inconsistent for the study follow up by investigator.
* Subject suffering from a chronic or acute pathology causing sleep disorders.
* Subject consuming products with impact on sleep deterioration at the moment of inclusion visit and throughout the study duration, belong to investigator.
* Subject having undergone general anesthesia during the month previous to inclusion visit.
* Subject suffering from eating disorders (anorexia, bulimia, etc.).
* Subject consuming more than 1.5 packet of tobacco per day (30 cigarettes/day or 27 mg of nicotine/day in electronic cigarette).
* Subject with history of known dependency to drugs or alcohol (consuming more than 3 alcohol units per day). In this study, 1 unit of alcohol is defined as 250 mL of beer, 100 mL of wine or 30 mL of spirits.
* Subject having under the care a child who as constant sleep troubles through the night.
* Subject with irregular working hours (day/night shifts, day/night duties, work trip during the study, etc.).
* Subject taking part in another clinical trial simultaneously and/or in the month previous to inclusion visit and/or being in exclusion period of a previous clinical trial.
* Woman planning to be pregnant soon, actually pregnant or lactating.
* Woman without efficient contraceptive method such as: hormonal contraception (including patch, contraceptive ring, etc.), uterine device or any other mechanic contraceptive method, or condom or diaphragm or spermicide, throughout the duration of the study.
* Subject with sensitivity or known allergy to the product used in the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT03514732
Study Brief:
Protocol Section:
NCT03514732