Sleep Disorders Related to AnxietyNCT02981238
Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of Eschscholtzia and Valerian Extracts
An observational study of Sleep Disorders Related to Anxiety, run by PiLeJe at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Sleep Disorders Related to Anxiety
- What is being tested?
- Phytostandard® Eschscholtzia / Valerian
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2016to 12 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from sleep disorders linked to anxiety
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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.
- Conditions
- Sleep Disorders Related to Anxiety
- Being tested
- Phytostandard® Eschscholtzia / Valerian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytostandard® Eschscholtzia / ValerianDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
evolution of the Index of Severity of Insomnia (ISI)
This outcome is compared with ISI at day 0 : we compared both the global score and each item scores
Measured: day 0 and day 28
Secondary outcomes (2)
Evolution of Hamilton Anxiety Scale (HAM-A)
This outcome is compared with HAM-A at day 0
Measured: day 0 and day 28
Percentage of Satisfaction
using a likert scale of satisfaction
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start20 Sep 2016
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorders Related to AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981238
- Sponsor's protocol ID
- PiL-Obs-SLEE-PI-015
- Status last verified
- Jul 2018
- First submitted
- 22 Nov 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02981238
- Acronym / sponsor ID
- PiL-Obs-SLEE-PI-015
- Conditions
- Sleep Disorders Related to Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from sleep disorders linked to anxiety
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phytostandard® Eschscholtzia / Valerian | Dietary supplement | – |
Primary outcome
evolution of the Index of Severity of Insomnia (ISI)
Time frame: day 0 and day 28
This outcome is compared with ISI at day 0 : we compared both the global score and each item scores
2 secondary outcomes
Evolution of Hamilton Anxiety Scale (HAM-A)
Time frame: day 0 and day 28
Percentage of Satisfaction
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Related trials for Sleep Disorders Related to Anxiety
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Not yet recruiting
Transdiagnostic Sleep Intervention to Improve Mental Health in Adolescents
Sleep Disturbance, Sleep Problems
Active, not recruiting
Rapid Entrainment and Signal-guided Neuromodulation for Behavioral Health
Anxiety, PTSD
Recruiting
Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study
Healthy Volunteer
Active, not recruiting
Early Psychological Intervention After Rape
Post Traumatic Stress Disorder, Rape Sexual Assault
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders Related to Anxiety, run by PiLeJe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evolution of the Index of Severity of Insomnia (ISI) (time frame: day 0 and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.