Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group (A) 120 mg of eschscholtzia extract and 50 mg of valerian extract by tablet, without support 28 days |
Dietary Supplement: Noctesia
3 tablets every day at bedtime with a large glass of water
|
| Placebo Comparator: Group (B) Placebo 28 days |
Dietary Supplement: Placebo
3 tablets every day at bedtime with a large glass of water
|
Outcome Measures
Primary Outcome Measures
- Sleep disorder severity [Baseline and D28 (end of supplementation)]
Change from baseline of Insomnia Severity Index (ISI) score
Secondary Outcome Measures
- 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
- 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
- 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
- Short-form 36 questionnaire (SF36) [Baseline and D28 (end of supplementation)]
Change from baseline of SF36 scores
- 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
- 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
- Addiction [Baseline and D49 (end of follow-up)]
Change from baseline of Addiction questionnaire scores
- Adverse events [Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up)]
Incidence of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Woman or man, aged of 18 to 65 years;
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In good general health as evidenced by medical history and physical examination;
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Having at least 3 episodes of sleep disorders per week including one or more of the following:
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difficulty falling asleep or
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difficulty staying asleep or
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poor quality sleep
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Waking up earlier than desired
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The insufficient sleep duration and quality is coupled with a feeling of general fatigue;
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Sleep disorder last for more than 1 month;
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Presenting moderate to severe sleep disorder in the past month (ISI ≥ 15);
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With anxiety resulting in a HAM-A score > 8 and < 25;
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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):
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Negative blood pregnancy test
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Acceptance to use an effective method of contraception, established for at least 1 month, and throughout the duration of the study;
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Fluent French speaking;
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Provision of signed and dated informed consent form;
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Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
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A score > 10 on the ESS scale (that would correspond to serious hypersomnia);
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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,… );
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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, …);
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Subjects presenting severe gastro-intestinal, hepatic, respiratory, kidney or cardiovascular disorder or severe infection (e.g. HIV, hepatitis, …);
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Acute or chronic somatic pathologies which can interfere with sleep: kidney cancer, etc.;
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Subjects with pre-menstrual syndrome or myasthenia gravis;
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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);
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Smoker;
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Subject consuming drugs and/or with historical drug addiction;
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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, .…);
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Volunteer with suicidal risk according to the investigator;
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Under phytotherapy treatment or food supplement for sleep disorders within the last month before screening;
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Volunteer presenting current infection and/or fever;
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Volunteer with medical history of stroke or head trauma;
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Pregnant or lactating woman;
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Known allergy or intolerance to one product component (valerian, eschscholtzia or excipients);
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Subjects having participated to another clinical trial (with an investigational product) one month before the inclusion;
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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;
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Vulnerable patient (deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice, …);
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Pharmacological resistance to common hypnotic/sedative drugs;
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Allergy/intolerance to the actimeter straps;
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Recent (< 1 month before the inclusion) change in lifestyle (food, body weight > 5kg, sport).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre d'Investigation Clinique en Nutrition | Louvain-la-Neuve | Belgium | B-1348 |
Sponsors and Collaborators
- PiLeJe
- Université Catholique de Louvain
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pil-Clin-Noct-020