Loading clinical trials...
Loading clinical trials...
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
Chronic insomnia affects a significant proportion of the French population with an estimated prevalence between 15% and 20%. This disease is mainly managed by general practitioners for whom benzodiazepines and Z-drugs (zopiclone, zolpidem) represent the first-line treatment. The french health authorities recommend limiting the consumption of these molecules to 2 to 4 weeks taking into account their possible undesirable effects (eg memory impairment, in the elderly, road accident) as well as the risk of tolerance and addiction. However, it appears that a majority of the patients concerned become chronic consumers. The investigators propose to assess cryo-auriculotherapy in the treatment of chronic insomnia. The population studied will consist of patients with chronic insomnia, whose diagnosis has been made according to the definition in the diagnostic and statistical manual of mental disorders (DSM-5), and followed up in an outpatient clinic at Foch Hospital or in one of the participating centers. Half of the patients will be treated with cryo-auriculotherapy (use of a device with nitrous oxide) and compared with control patients who will have the same treatment visits involving a sham device (device without nitrous oxide).
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
No
Espace Santé Simone Veil
Issy-les-Moulineaux, Hauts de Seine, France
Cabinet Médical Nouvelle France
Le Chesnay, Yvelines, France
Cabinet de l'Olivier
Montigny-le-Bretonneux, Yvelines, France
Hopital Foch
Suresnes, France
Start Date
October 14, 2020
Primary Completion Date
October 14, 2025
Completion Date
October 14, 2025
Last Updated
April 3, 2025
72
ESTIMATED participants
Cryo-Auriculotherapy
DEVICE
Sham comparator
DEVICE
Lead Sponsor
Hopital Foch
NCT07429578
NCT06968013
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05813392