Chronic InsomniaAURICULO-DODONCT04471168
Interest of Auriculotherapy in the Management of Chronic Insomnia
A study testing Cryo-Auriculotherapy in people with Chronic Insomnia, run by Hopital Foch at 4 sites in France.
Trial summary
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Cryo-Auriculotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 4 sitesFrance
- Study dates
- 14 Oct 2020to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Espace Santé Simone Veil
Issy-les-Moulineaux, Hauts de Seine, 97132
Cabinet Médical Nouvelle France
Le Chesnay, Yvelines, 78158
Cabinet de l'Olivier
Montigny-le-Bretonneux, Yvelines, 78423
Hopital Foch
Suresnes, 92150
About this study
The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.
Read the 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
- Being tested
- Cryo-Auriculotherapy, Sham comparator
- Keywords
- Cryo auriculotherapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo-AuriculotherapyDevice
3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
Sham comparatorDevice
3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
| Study group | Role | What they receive |
|---|---|---|
| Cryo-Auriculotherapy | Experimental | Patients benefit from 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals. Receives: Device: Cryo-Auriculotherapy |
| Control group | Sham comparator | Patients benefit from 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals. Receives: Device: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (7)
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.
Measured: 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)
Measured: 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.
Measured: 3 months
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).
Measured: 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'
Measured: 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
Measured: 3 months
Tolerance of cryotherapy auriculotherapy treatment.
The presence or absence of adverse events attributed to the treatment of auriculotherapy by the patient.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start14 Oct 2020
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471168
- Sponsor's protocol ID
- 2018_0107
- Acronym
- AURICULO-DODO
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Auriculotherapy in the Management of Chronic Insomnia
- ClinicalTrials.gov ID
- NCT04471168
- Acronym / sponsor ID
- AURICULO-DODO / 2018_0107
- Conditions
- Chronic Insomnia
- Keywords
- Cryo auriculotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryo-Auriculotherapy | Experimental | Device: Cryo-AuriculotherapyPatients benefit from 3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals. |
| Control group | Sham comparator | Device: Sham comparatorPatients benefit from 3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryo-Auriculotherapy3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals. | Device | Cryo-Auriculotherapy |
| Sham comparator3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals. | Device | Control group |
Primary outcome
Number of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
Time frame: 3 months
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.
7 secondary outcomes
Evolution of sleep quality and sleep disorders
Time frame: 3 months
Evolution of drug consumption linked to chronic insomnia
Time frame: 3 months
Evolution and Anxiety and depression
Time frame: 3 months
Evolution of quality of life
Time frame: 3 months
Overall patient impression
Time frame: 3 months
Willingness of the patient to continue treatment
Time frame: 3 months
Tolerance of cryotherapy auriculotherapy treatment.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireille Michel-Cherqui, MD principal investigator
Hopital Foch
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryo-Auriculotherapy in people with Chronic Insomnia, run by Hopital Foch at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improvement of insomnia after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.