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 @ 12:55 PM
Ignite Modification Date:
2025-12-24 @ 12:55 PM
NCT ID:
NCT04245761
Eligibility Criteria:
Inclusion Criteria:
1. Men and women, aged 18 to 70 years with persistent, recent (at least 1 month) and mild sleep disorders related to pre-sleep arousal and reduced quality of sleeping;
2. PSAS at baseline between 16 and 24;
3. ISI at baseline ≥ 12;
4. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study;
5. Capable of and freely willing to provide written informed consent prior to participating in the study;
Exclusion Criteria:
l. Subjects with Morningness-Eveningness Questionnaire Self-Assessment (MEQSA) values between 16 and 41; 2. Pregnancy and/or breast-feeding; 3. Subjects assuming beta blockers, hypnotic or sedative drugs or other nutraceuticals; 4. Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt, or suicidal ideation, or any other psychiatric illness (with the exception of intermittent anxiety); 5. Known intolerance to the tested product or at one of the ingredients (hawthorn, lavender or hop); 6. Drug or alcohol abuse within 12 months of Day 0; 7. All clinical conditions that, at the evaluation of the Investigator, can be referred to as secondary insomnia; 8. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days; 9. Presence of any clinically significant medical condition judged by the investigator to preclude the subject's inclusion in the study;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04245761
Study Brief:
Protocol Section:
NCT04245761