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

Not Applicable

Completed

• Conditions: Sleep Troubles Associated With Anxiety
• Interventions: Dietary Supplement: Noctesia; Dietary Supplement: Placebo

• Registration Number: NCT04812418
• Lead Sponsor: PiLeJe

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-03-29
• Primary Completion: 2023-05-17
• Study Completion: 2023-06-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (A)	Noctesia	120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days
Group (B)	Placebo	Placebo 28 days

Primary Outcome Measures

Name	Time	Method
Sleep disorder severity	Baseline and D28 (end of supplementation)	Change from baseline of Insomnia Severity Index (ISI) score

Secondary Outcome Measures

Name	Time	Method
Patient assessment of sleep disorder symptoms improvement after intervention	Baseline and D28 (end of supplementation)	Change from baseline of Patient Global Impression Improvement (PGI-I) score
Short-form 36 questionnaire (SF36)	Baseline and D28 (end of supplementation)	Change from baseline of SF36 scores
Anxiety status	Baseline and D28 (end of supplementation)	Change from baseline of Hamilton anxiety rating scale (HAM-A) score
Anxiety status over time	Baseline and D49 (end of follow-up)	Change from baseline of Hamilton anxiety rating scale (HAM-A) score
Electronic sleep diaries	Baseline, D7, D14, D21 and D28 (end of supplementation)	Change from baseline of the mean values obtained from electronic sleep diaries during the 7 days
Evolution of sleep troubles	Baseline, D28 (end of supplementation) and D49 (end of follow-up)	Change from baseline of sleep troubles regarding changes in medical prescriptions, reason of changes and number of intercurrent medical visits for sleep disorders
Adverse events	Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up)	Incidence of adverse events
Addiction	Baseline and D49 (end of follow-up)	Change from baseline of Addiction questionnaire scores
Sleep disorder severity over time	Baseline and D49 (end of follow-up)	Change from baseline of Insomnia Severity Index (ISI) score
Investigator assessment of sleep disorder symptoms severity	Baseline and D28 (end of supplementation)	Change from baseline of Clinical Global Impression Severity (CGI-S) score
Investigator assessment of sleep disorder symptoms improvement	Baseline and D28 (end of supplementation)	Change from baseline of Clinical Global Impression Improvement (CGI-I) score
Actimeters	Baseline, D7, D14, D21 and D28 (end of supplementation)	Change from baseline of the mean values obtained from actimeters recording during the 7 days

Trial Locations

Locations (1)

Centre d'Investigation Clinique en Nutrition; 🇧🇪 Louvain-la-Neuve, Belgium