Clinical trial NCT04812418: Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
Official title: Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Troubles Associated With Anxiety
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
Collaborators: name: Université Catholique de Louvain
First posted: 2021-03-23
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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).

Primary outcomes:
measure: Sleep disorder severity
timeFrame: Baseline and D28 (end of supplementation)
Secondary outcomes:
measure: Sleep disorder severity over time
timeFrame: Baseline and D49 (end of follow-up)
measure: Investigator assessment of sleep disorder symptoms severity
timeFrame: Baseline and D28 (end of supplementation)
measure: Investigator assessment of sleep disorder symptoms improvement
timeFrame: Baseline and D28 (end of supplementation)
measure: Patient assessment of sleep disorder symptoms improvement after intervention
timeFrame: Baseline and D28 (end of supplementation)
measure: Anxiety status
timeFrame: Baseline and D28 (end of supplementation)
measure: Anxiety status over time
timeFrame: Baseline and D49 (end of follow-up)
measure: Short-form 36 questionnaire (SF36)
timeFrame: Baseline and D28 (end of supplementation)
measure: Actimeters
timeFrame: Baseline, D7, D14, D21 and D28 (end of supplementation)
measure: Electronic sleep diaries
timeFrame: Baseline, D7, D14, D21 and D28 (end of supplementation)
measure: Evolution of sleep troubles
timeFrame: Baseline, D28 (end of supplementation) and D49 (end of follow-up)
measure: Addiction
timeFrame: Baseline and D49 (end of follow-up)
measure: Adverse events
timeFrame: Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up)
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Centre d'Investigation Clinique en Nutrition
Study officials:
References: