Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo

NCT ID: NCT04812418

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2023-06-09

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.

Conditions

Sleep Troubles Associated With Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group (A)

120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days

Group Type: EXPERIMENTAL

Noctesia

Intervention Type: DIETARY_SUPPLEMENT

3 tablets every day at bedtime with a large glass of water

Group (B)

Placebo 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

3 tablets every day at bedtime with a large glass of water

Interventions

Noctesia

3 tablets every day at bedtime with a large glass of water

Intervention Type: DIETARY_SUPPLEMENT

Placebo

3 tablets every day at bedtime with a large glass of water

Intervention Type: DIETARY_SUPPLEMENT

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

PiLeJe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre d'Investigation Clinique en Nutrition

Louvain-la-Neuve, , Belgium

Countries

Belgium

Other Identifiers

Pil-Clin-Noct-020

Identifier Type: -

Identifier Source: org_study_id