Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-01 @ 4:44 PM
Study NCT ID:
NCT04471168
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2020-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Auriculotherapy in the Management of Chronic Insomnia
Sponsor:
Hopital Foch
Organization:
Study Overview
Official Title:
Interest of Auriculotherapy in the Management of Chronic Insomnia
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AURICULO-DODO
Brief Summary:
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: