Sleep Disorders Related to Anxiety
Conditions
Brief summary
The aim of the study is to evaluate the effect of a one-month supplementation with Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac so-called adjustment subjects (occasional or short-term insomnia)
Detailed description
For this study, 40 patients are going to be included. They will have a supplementation of Phytostandard® Eschscholtzia and valerian, from 2 to 4 tablets per day during 28 days. on the one hand, during the two visits (inclusion and follow-up), the investigator completes the Hamilton Anxiety Scale (HAM-A). During the inclusion visit, he completes with his patient the epworth scale. on the other hand, patients complete ISI twice : just after the inclusion visit and just before the follow-up visit. He completes two sleep schedules, the first one during the first week of complement and the second one during the fourth.
Interventions
DIETARY_SUPPLEMENTPhytostandard® Eschscholtzia / Valerian
Sponsors
PiLeJe
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
of patients: * Currently having sleep disorders related to an anxiety and / or having some in the last 3 months * Having an alteration of sleep on the previous month which results in a score strictly greater than 7 according to the index of Severity of Insomnia (ISI) * For which the investigator freely advises his patient a complement with Phytostandard® Eschscholtzia and Valerian * For which the patient freely agrees to complement itself after advice of his doctor with Phytostandard® Eschscholtzia and Valerian * Having been informed of the study and accepting the collection and processing of their data
Exclusion criteria
* Suffering from an anxiety resulting in a HAM-A score (Hamilton Anxiety Rating Scale) greater than or equal to 30 * With a score on Epworth's sleepiness scale strictly greater than 10 (suggestive of a major hypersomnia) * Presenting symptoms of sleep apnea syndrome * Presenting symptoms of a restless legs syndrome * Presenting a chronic pain syndrome requiring the daily intake of analgesic(s) * Under psychotropic treatment (neuroleptic, anxiolytic, antidepressant or hypnotic) or under treatment to alter the waking state (antihistamines, beta-blockers, some cough syrups, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evolution of the Index of Severity of Insomnia (ISI) | day 0 and day 28 | This outcome is compared with ISI at day 0 : we compared both the global score and each item scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Hamilton Anxiety Scale (HAM-A) | day 0 and day 28 | This outcome is compared with HAM-A at day 0 |
| Percentage of Satisfaction | day 28 | using a likert scale of satisfaction |
Countries
France
Outcome results
None listed