NCT04471168

Interest of Auriculotherapy in the Management of Chronic Insomnia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DEVICE	Cryo-Auriculotherapy	3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
DEVICE	Sham comparator	3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.

Timeline

• Start date: 2020-10-14
• Primary completion: 2025-10-14
• Completion: 2025-10-14
• First posted: 2020-07-15
• Last updated: 2025-04-03

Locations

4 sites across 1 country: France