Clinical trial NCT02981238: Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of Eschscholtzia and Valerian Extracts
Official title: Descriptive Study of a Phytotherapy Strategy for Sleep Disorders Related to Anxiety With Phytostandard® Eschscholtzia and Valerian, a Dietary Supplement Based on Eschscholtzia and Valerian Extracts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders Related to Anxiety
Lead sponsor: PiLeJe
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from sleep disorders linked to anxiety

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: evolution of the Index of Severity of Insomnia (ISI)
timeFrame: day 0 and day 28
Secondary outcomes:
measure: Evolution of Hamilton Anxiety Scale (HAM-A)
timeFrame: day 0 and day 28
measure: Percentage of Satisfaction
timeFrame: day 28
Other outcomes:
Locations:
city: Paris
country: France
facility: Pileje Network of general practitioners
Study officials:
References: