Sleep Troubles Associated With Anxiety Clinical Trial
Official title:
Evaluation of a Combination of Plants in Anxiety-related Sleep Disorders: Randomized Trial Versus Placebo
| Verified date | November 2023 |
| Source | Larena SAS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | June 9, 2023 |
| Est. primary completion date | May 17, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Centre d'Investigation Clinique en Nutrition | Louvain-la-Neuve |
| Lead Sponsor | Collaborator |
|---|---|
| PiLeJe | Université Catholique de Louvain |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sleep disorder severity | Change from baseline of Insomnia Severity Index (ISI) score | Baseline and D28 (end of supplementation) | |
| Secondary | Sleep disorder severity over time | Change from baseline of Insomnia Severity Index (ISI) score | Baseline and D49 (end of follow-up) | |
| Secondary | Investigator assessment of sleep disorder symptoms severity | Change from baseline of Clinical Global Impression Severity (CGI-S) score | Baseline and D28 (end of supplementation) | |
| Secondary | Investigator assessment of sleep disorder symptoms improvement | Change from baseline of Clinical Global Impression Improvement (CGI-I) score | Baseline and D28 (end of supplementation) | |
| Secondary | Patient assessment of sleep disorder symptoms improvement after intervention | Change from baseline of Patient Global Impression Improvement (PGI-I) score | Baseline and D28 (end of supplementation) | |
| Secondary | Anxiety status | Change from baseline of Hamilton anxiety rating scale (HAM-A) score | Baseline and D28 (end of supplementation) | |
| Secondary | Anxiety status over time | Change from baseline of Hamilton anxiety rating scale (HAM-A) score | Baseline and D49 (end of follow-up) | |
| Secondary | Short-form 36 questionnaire (SF36) | Change from baseline of SF36 scores | Baseline and D28 (end of supplementation) | |
| Secondary | Actimeters | Change from baseline of the mean values obtained from actimeters recording during the 7 days | Baseline, D7, D14, D21 and D28 (end of supplementation) | |
| Secondary | Electronic sleep diaries | Change from baseline of the mean values obtained from electronic sleep diaries during the 7 days | Baseline, D7, D14, D21 and D28 (end of supplementation) | |
| Secondary | Evolution of sleep troubles | Change from baseline of sleep troubles regarding changes in medical prescriptions, reason of changes and number of intercurrent medical visits for sleep disorders | Baseline, D28 (end of supplementation) and D49 (end of follow-up) | |
| Secondary | Addiction | Change from baseline of Addiction questionnaire scores | Baseline and D49 (end of follow-up) | |
| Secondary | Adverse events | Incidence of adverse events | Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up) |