Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
The objective of this double-blind randomized clinical trial is to compare the effects of a
 dietary supplement based on eschscholtzia and valerian extracts to a placebo after 28 days of
 supplementation, in subjects suffering from sleep troubles associated with anxiety.
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).