Sleep Troubles Associated With Anxiety
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNoctesia
3 tablets every day at bedtime with a large glass of water
DIETARY_SUPPLEMENTPlacebo
3 tablets every day at bedtime with a large glass of water
Sponsors
Université Catholique de Louvain
PiLeJe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep disorder severity | Baseline and D28 (end of supplementation) | Change from baseline of Insomnia Severity Index (ISI) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Adverse events | Baseline D7, D14, D21, D28 (end of supplementation) and D49 (end of follow-up) | Incidence of adverse events |
| 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 |
| Anxiety status over time | Baseline and D49 (end of follow-up) | Change from baseline of Hamilton anxiety rating scale (HAM-A) score |
Countries
Belgium
Outcome results
None listed