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Ear freezing therapy tested for insomnia – does it work?

NCT ID NCT04471168

Symptom relief Sponsor: Hopital Foch Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a technique called cryo-auriculotherapy, where a device freezes specific spots on the ear, to see if it helps people with chronic insomnia. Sixty-five adults with moderate to severe insomnia received either real or sham (fake) treatments over three months. The main goal was to see if the real treatment led to a bigger drop in insomnia scores compared to the sham.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryo-auriculotherapy (ear freezing device)
What this could lead to
If it works, this could offer a non-drug option for managing chronic insomnia.
What could go wrong
This is a small, completed trial with only 65 participants. The improvement measured is modest (3-point drop on a sleep scale), and the sham group also received a procedure, so the real benefit may be small or due to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

65 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic insomnia

Contacts and locations

Locations

  • Cabinet Médical Nouvelle France

    Le Chesnay, Yvelines, 78158, France

  • Cabinet de l'Olivier

    Montigny-le-Bretonneux, Yvelines, 78423, France

  • Espace Santé Simone Veil

    Issy-les-Moulineaux, Hauts de Seine, 97132, France

  • Hopital Foch

    Suresnes, 92150, France

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