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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT05194618
Eligibility Criteria:
Inclusion Criteria:
1. Adult subjects (≥ 18 years old) with sleep complaints:
* with a frequency of 1 or 2 times per week, OR
* with a frequency ≥ 3 times per week and duration \< 3 months,
Sleep complaints are defined as:
* Difficulty initiating sleep, or
* Difficulty maintaining sleep, or
* Early-morning awakening with inability to return to sleep. and
* Causing distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
2. Insomnia Severity Index (ISI) score comprised between 11 and 21 (slight to moderate sleep complaints)
3. BMI inferior to 30 (included)
4. Connected to internet and having a smartphone
5. Affiliated person or beneficiary of a social security scheme
6. Free, informed and written consent signed
Exclusion Criteria:
1. Severe sleep complaints (ISI \> 21) OR insomnia with clinical significance consequences as defined by DSM 5
2. Subject with other organic sleep disorders diagnosed (i.e. sleep apnea, Restless Legs Syndrome)
3. Subject at high risk of suspicion of Obstructive Sleep Apnea Syndrome (OSAS) on the STOP-BANG questionnaire (Snoring, Tiredness, Observed apnea, blood Pressure, Body mass index, Age, Neck circumference and Gender), or a suspicion of Restless Legs Syndrome (RLS) on the RLS screening questionnaire,
4. Subject with a significant medical history in the previous year or still in progress (example: Cancer),
5. Subject with acute psychiatric disorder (mood disorders, severe anxiety disorders, psychosis, addiction interfering with nocturnal sleep). Subject with a history of mood or anxiety disorder currently stabilized could be included.
6. Having initiated a psychotropic treatment for anxiety or mood disorders in the last 2 months or whose treatment dose has been modified for less than 2 months (antidepressant, anxiolytic and antihistamine treatments will be allowed if they are prescribed for a stabilized mood and/or anxiety disorder)
7. Having organic disorders inducing sleep complaints (i.e. Covid \< 6 months)
8. Currently treated for insomnia disorders with a pharmaceutical treatment (hypnotic treatments, anxiolytic, antidepressants).
9. Taking food supplements aimed at improving sleep quality in the previous month,
10. Taking food supplements in the previous month containing valerian root extract or lavender oil
11. Taking any pharmaceutical treatment suspected to induce sleep complaints
12. Shift workers and social jet lag
13. Having undertaken trans-meridian travel (± 3H) in the previous month and/or refusing not to undertake trans-meridian travel (± 3H) )
14. Known drug abuse
15. Alcohol consumption more than 10 standard drinks per week
16. Caffeine consumption more than 5 standard cups/drinks per day
17. Participation in a clinical trial in the previous 3 months that may interfere with the evaluation of the primary endpoint (sleep complaints) or exclusion period still on going
18. Eating disorders: anorexia and bulimia or unstable dietary pattern;
19. Any food allergy documented or suspected to one of the components of the study products;
20. Pregnancy or breast-feeding woman (contraceptive mandatory)
21. Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05194618
Study Brief:
Protocol Section:
NCT05194618