InsomniaCyclamaxNCT00484497
Evaluation of a Food Supplement on Sleep Quality
A study testing cyclamax in people with Insomnia, run by Persee Medica at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- cyclamax
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to not given
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer aged between 25 to 65 years
- Patient diagnosed for primary Insomnia (threshold for inclusion: 10 on the ISI scale)
- Healthy volunteer without diurnal sleep (total score for inclusion must be less than 10 on the Epworth scale)
- Patient affiliated to the French Social Security
- Patient who gave written informed consent
Who cannot join
- Secondary insomnia
- History of severe psychiatric disorder, assessed by the MINI test
- Resistance to Hypnotic drugs
- Anxiety, depression, suicide, detected by the Beck Depression Inventory
- Acute Pathology during the precedent three years
- Breast feeding and pregnancy women
- Non compliant volunteer
- Hypersensibility to treatment composant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient
The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
- Conditions
- Insomnia
- Being tested
- cyclamax
- Keywords
- Sleep quality, food supplement, randomized controlled trial, actigraphy, Leeds, Volunteers presenting moderate primary insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclamaxDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
Secondary outcomes (6)
Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal
Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants
Sleep efficiency measured by ambulatory actigraphy (2 period)
Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment)
Clinical General Impression of the clinician, before and after treatment.
Safety of the treatment (adverse event reporting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Persee Medica
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine Cornu, MD, Principal investigator, Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484497
- Sponsor's protocol ID
- DGS2006/0492
- Acronym
- Cyclamax
- Status last verified
- Jun 2007
- First submitted
- 1 Jun 2007
- Last updated
- 11 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Cornu C, Remontet L, Noel-Baron F, Nicolas A, Feugier-Favier N, Roy P, Claustrat B, Saadatian-Elahi M, Kassai B. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial. BMC Complement Altern Med. 2010 Jun 22;10:29. doi: 10.1186/1472-6882-10-29.
PubMed 20569455
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient
- ClinicalTrials.gov ID
- NCT00484497
- Acronym / sponsor ID
- Cyclamax / DGS2006/0492
- Conditions
- Insomnia
- Keywords
- Sleep quality, food supplement, randomized controlled trial, actigraphy, Leeds, Volunteers presenting moderate primary insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Persee MedicaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- First posted
- 11 Jun 2007 (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 purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteer aged between 25 to 65 years
- Patient diagnosed for primary Insomnia (threshold for inclusion: 10 on the ISI scale)
- Healthy volunteer without diurnal sleep (total score for inclusion must be less than 10 on the Epworth scale)
- Patient affiliated to the French Social Security
- Patient who gave written informed consent
Key exclusion criteria (8 listed)
- Secondary insomnia
- History of severe psychiatric disorder, assessed by the MINI test
- Resistance to Hypnotic drugs
- Anxiety, depression, suicide, detected by the Beck Depression Inventory
- Acute Pathology during the precedent three years
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 |
|---|---|---|
| cyclamax | Drug | – |
Primary outcome
Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment
6 secondary outcomes
Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal
Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants
Sleep efficiency measured by ambulatory actigraphy (2 period)
Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment)
Clinical General Impression of the clinician, before and after treatment.
Safety of the treatment (adverse event reporting)
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 11 Jun 2007.
- Derived from this study: PubMed 20569455Cornu C, Remontet L, Noel-Baron F, Nicolas A, Feugier-Favier N, Roy P, Claustrat B, Saadatian-Elahi M, Kassai B. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial. BMC Complement Altern Med. 2010 Jun 22;10:29. doi: 10.1186/1472-6882-10-29.
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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.
Catherine Cornu, MD principal investigator
Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cyclamax in people with Insomnia, run by Persee Medica 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 8 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 11 Jun 2007. 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?
Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484497, which also lists 1 linked publication.
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 11 Jun 2007.