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Completed

NCT Number: NCT00484497

Evaluation of a Food Supplement on Sleep Quality

The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center- Hopital Cardiologique

Lyon, 69677, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

cyclamax

Drug

Primary outcomes

  1. Sleep quality assessed by the Leed Sleep Evaluation Questionnaire, measured after one month of treatment

Secondary outcomes

  1. Sleep quality assessed by the Leed Sleep Evaluation - Questionnaire, measured 15 days after treatment withdrawal

  2. Sleep quality assessed by a Sleep diary completed each day during all the study period by the participants

  3. Sleep efficiency measured by ambulatory actigraphy (2 period)

  4. Evolution of melatonin/6sulfatoxymelatonin ratio (before and after treatment)

  5. Clinical General Impression of the clinician, before and after treatment.

  6. Safety of the treatment (adverse event reporting)

Sponsors and collaborators

Lead sponsor

Persee Medica

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Trial for the Evaluation of a Food Supplement on Sleep Quality in Primary Insomnia Patient

Acronym: Cyclamax

Important dates

Study start
2006
First posted
Jun 11, 2007
Registry last updated
Jun 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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