Back to resultsInterest of Auriculotherapy in the Management of Chronic Insomnia (AURICULO-DODO)
Primary Purpose
Chronic Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cryo-Auriculotherapy
Sham comparator
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Cryo auriculotherapy
Eligibility Criteria
Inclusion Criteria:
- Suffering from chronic insomnia as defined in the diagnostic and statistical manual of mental disorders (DSM-5)
- Score ≥ 15 on the Insomnia Severity Index (ISI) questionnaire;
- Covered by a national healthcare insurance
- Consent form signed
Exclusion Criteria:
- Pregnant woman or pregnancy planned for the duration of the study;
- Regular night work or shift work / reversal of sleep patterns;
- Trans meridian travel during the previous month or planned during the study period;
- Unstable or untreated psychiatric disorder including severe depression, severe addiction, unbalanced bipolar disorder;
- Taking insomnia-inducing drugs (eg Corticoids);
- Hypnotic treatment or antidepressant treatment with hypnotic aim introduced since less than 4 weeks or with change dating back less than 4 weeks;
- Presence of organic comorbidities which may be responsible for sleep disorders (SAS and restless legs syndrome): (STOP-BANG) score ≥ 5;
- History of central neurological disorders or progressive brain injury;
- Contraindication to the use of auriculotherapy (lesion or infection of the pinna) by cryotherapy (skin scarring disorder, risk of hypo or hyperpigmentation);
- Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
- Previous treatment with cryo-auriculotherapy
- Having started in the month preceding the first auriculotherapy session, any new treatment likely to interfere with the study: specific drug treatment (antidepressant, morphine or anticonvulsant) or complementary therapy (psychological care, physiotherapy, balneotherapy, etc.).
- Difficulty complying with the treatment, questionnaire or study protocol.
- Be deprived of liberty or under guardianship.
Sites / Locations
- Espace Santé Simone VeilRecruiting
- Cabinet Médical Nouvelle France
- Cabinet de l'Olivier
- Hopital FochRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Cryo-Auriculotherapy
Control group
Arm Description
Patients benefit from 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
Patients benefit from 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
Outcomes
Primary Outcome Measures
Number 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.
Secondary Outcome Measures
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.
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)
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.
Evolution of quality of life
EuroQoL 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).
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'
Willingness of the patient to continue treatment
Patient will be asked at the end of the study if they want to pursue the treatment
Tolerance of cryotherapy auriculotherapy treatment.
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04471168
Brief Title
Interest of Auriculotherapy in the Management of Chronic Insomnia
Acronym
AURICULO-DODO
Official Title
Interest of Auriculotherapy in the Management of Chronic Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Cryo auriculotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryo-Auriculotherapy
Arm Type
Experimental
Arm Description
Patients benefit from 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patients benefit from 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
Intervention Type
Device
Intervention Name(s)
Cryo-Auriculotherapy
Intervention Description
3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
Intervention Type
Device
Intervention Name(s)
Sham comparator
Intervention Description
3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
Primary Outcome Measure Information:
Title
Number of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
Description
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
Secondary Outcome Measure Information:
Title
Evolution of sleep quality and sleep disorders
Description
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
Title
Evolution of drug consumption linked to chronic insomnia
Description
Drugs used to control chronic insomnia will be collected from the inclusion to 3 months (1 month post-treatment)
Time Frame
3 months
Title
Evolution and Anxiety and depression
Description
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
Title
Evolution of quality of life
Description
EuroQoL 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
Title
Overall patient impression
Description
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
Title
Willingness of the patient to continue treatment
Description
Patient will be asked at the end of the study if they want to pursue the treatment
Time Frame
3 months
Title
Tolerance of cryotherapy auriculotherapy treatment.
Description
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suffering from chronic insomnia as defined in the diagnostic and statistical manual of mental disorders (DSM-5)
Score ≥ 15 on the Insomnia Severity Index (ISI) questionnaire;
Covered by a national healthcare insurance
Consent form signed
Exclusion Criteria:
Pregnant woman or pregnancy planned for the duration of the study;
Regular night work or shift work / reversal of sleep patterns;
Trans meridian travel during the previous month or planned during the study period;
Unstable or untreated psychiatric disorder including severe depression, severe addiction, unbalanced bipolar disorder;
Taking insomnia-inducing drugs (eg Corticoids);
Hypnotic treatment or antidepressant treatment with hypnotic aim introduced since less than 4 weeks or with change dating back less than 4 weeks;
Presence of organic comorbidities which may be responsible for sleep disorders (SAS and restless legs syndrome): (STOP-BANG) score ≥ 5;
History of central neurological disorders or progressive brain injury;
Contraindication to the use of auriculotherapy (lesion or infection of the pinna) by cryotherapy (skin scarring disorder, risk of hypo or hyperpigmentation);
Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
Previous treatment with cryo-auriculotherapy
Having started in the month preceding the first auriculotherapy session, any new treatment likely to interfere with the study: specific drug treatment (antidepressant, morphine or anticonvulsant) or complementary therapy (psychological care, physiotherapy, balneotherapy, etc.).
Difficulty complying with the treatment, questionnaire or study protocol.
Be deprived of liberty or under guardianship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mireille Michel-Cherqui, MD
Phone
+33(0)146252985
Email
m.michel-cherqui@hopital-foch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Espace Santé Simone Veil
City
Issy-les-Moulineaux
State/Province
Hauts De Seine
ZIP/Postal Code
97132
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina MA, MD
Email
sabrina.ma@ville-issy.fr
First Name & Middle Initial & Last Name & Degree
Sabrina MA, MD
Facility Name
Cabinet Médical Nouvelle France
City
Le Chesnay
State/Province
Yvelines
ZIP/Postal Code
78158
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Cabinet de l'Olivier
City
Montigny-le-Bretonneux
State/Province
Yvelines
ZIP/Postal Code
78423
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Phone
+33(0)146252985
Email
m.michel-cherqui@hopital-foch.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Interest of Auriculotherapy in the Management of Chronic Insomnia
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