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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT04812418
Eligibility Criteria:
Inclusion Criteria:
* Woman or man, aged of 18 to 65 years;
* In good general health as evidenced by medical history and physical examination;
* Having at least 3 episodes of sleep disorders per week including one or more of the following:
1. difficulty falling asleep or
2. difficulty staying asleep or
3. poor quality sleep
4. Waking up earlier than desired
* The insufficient sleep duration and quality is coupled with a feeling of general fatigue;
* Sleep disorder last for more than 1 month;
* Presenting moderate to severe sleep disorder in the past month (ISI ≥ 15);
* With anxiety resulting in a HAM-A score \> 8 and \< 25;
* For women of childbearing age (women of childbearing potential, pre-menopausal or having postmenopausal amenorrhea of less than 12 months, and women who have not undergone surgical sterilization):
1. Negative blood pregnancy test
2. Acceptance to use an effective method of contraception, established for at least 1 month, and throughout the duration of the study;
* Fluent French speaking;
* Provision of signed and dated informed consent form;
* Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
* A score \> 10 on the ESS scale (that would correspond to serious hypersomnia);
* Sleep disorders secondary to another health problem (sleep apnea syndrome, narcolepsy-cataplexy, idiopathic hypersomnia, restless legs syndrome, chronic pain syndrome, ...) or an environmental factor (noise, light ...) or socio-professional (shift work, young child at home, people who are often jet lagged,… );
* Severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia,…) or a severe neurologic trouble (Alzheimer's, autism, Parkinson's disease, …);
* Subjects presenting severe gastro-intestinal, hepatic, respiratory, kidney or cardiovascular disorder or severe infection (e.g. HIV, hepatitis, …);
* Acute or chronic somatic pathologies which can interfere with sleep: kidney cancer, etc.;
* Subjects with pre-menstrual syndrome or myasthenia gravis;
* Subjects who drink more than 2 glasses of alcohol per day (\> 20g of alcohol per day) or with exaggerated consumption of theine (≥ 1l per day) and caffeine-rich (≥ 800ml per day) beverages and energy drink (≥ 330ml per day);
* Smoker;
* Subject consuming drugs and/or with historical drug addiction;
* Under psychotropic treatment within the last month before screening (neuroleptic, anxiolytic, antidepressant, hypnotic, sedative, …) or under current medication treatment which may alter the waking state (for example: cortisone, dopamine, amphetamine, antihistamines, beta-blockers, certain cough syrups, .…);
* Volunteer with suicidal risk according to the investigator;
* Under phytotherapy treatment or food supplement for sleep disorders within the last month before screening;
* Volunteer presenting current infection and/or fever;
* Volunteer with medical history of stroke or head trauma;
* Pregnant or lactating woman;
* Known allergy or intolerance to one product component (valerian, eschscholtzia or excipients);
* Subjects having participated to another clinical trial (with an investigational product) one month before the inclusion;
* Subjects that present alterations of their cognitive functions that will interfere with the comprehension of the study and procedures and/or with the completion of questionnaires;
* Vulnerable patient (deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice, …);
* Pharmacological resistance to common hypnotic/sedative drugs;
* Allergy/intolerance to the actimeter straps;
* Recent (\< 1 month before the inclusion) change in lifestyle (food, body weight \> 5kg, sport).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04812418
Study Brief:
Protocol Section:
NCT04812418