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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
Espace Santé Simone Veil
Issy-les-Moulineaux, Hauts de Seine, France
RECRUITINGCabinet Médical Nouvelle France
Le Chesnay, Yvelines, France
ACTIVE_NOT_RECRUITINGCabinet de l'Olivier
Montigny-le-Bretonneux, Yvelines, France
ACTIVE_NOT_RECRUITINGNumber of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
Comparison of the evolution of the score of the Insomnia Severity Index (7-item self-report questionnaire assessing the nature, severity, and impact of insomnia). Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The improvement will be defined as a decrease in the score of the questionnaire by 3 points between Day 90 and Day 0. A comparison of the improvement according to the 2 arms will be made.
Time frame: 3 months
Evolution of sleep quality and sleep disorders
Specific questionnaire Pittsburgh Sleep Quality Index (PSQI)at inclusion and at 3 months (1 month post-treatment). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: 3 months
Evolution of drug consumption linked to chronic insomnia
Drugs used to control chronic insomnia will be collected from the inclusion to 3 months (1 month post-treatment)
Time frame: 3 months
Evolution and Anxiety and depression
Hospital Anxiety and Depression questionnaire will be used at inclusion and at 3 months post-treatment. There are seven questions related to anxiety (total A) and seven others related to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21). Higher score indicates a certain symptomatology : * 7 or less: absence of symptoms * 8 to 10: doubtful symptomatology * 11 and more: certain symptomatology.
Time frame: 3 months
Evolution of quality of life
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Hopital Foch
Suresnes, France
RECRUITINGEuroQoL five Dimension questionnaire at inclusion and at 3 months post-treatment. This questionnaire is designed for the patient to judge the impact of his state of health on his quality of life according to 5 dimensions (mobility, personal autonomy, daily activities, pain / discomfort and anxiety / depression). Each item has 3 response levels (1, 2 and 3) and the combination of the five digits will represent the patient's state of health. It is supplemented by a quality of life thermometer graduated from 0 (worst quality of life) to 100 (best quality of life).
Time frame: 3 months
Overall patient impression
Patient Global Impression of Change questionnaire (PGIC) used at the end of the follow-up. This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status with a seven-point single-item scale ranging from 'very much worse' to 'very much improved'
Time frame: 3 months
Willingness of the patient to continue treatment
Patient will be asked at the end of the study if they want to pursue the treatment
Time frame: 3 months
Tolerance of cryotherapy auriculotherapy treatment.
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Time frame: 3 months