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The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclamax | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Cornu, MD | Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center- Hopital Cardiologique | Lyon | 69677 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20569455 | Derived | 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. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 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) |
| D001523 |
| Mental Disorders |