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Exercise program aims to fix sleep in alcohol recovery

NCT ID NCT06706349

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a supervised exercise program can improve sleep in people with alcohol use disorder. Forty adults with sleep problems will take part in activities like walking, cycling, and yoga. Researchers will track sleep quality, melatonin levels, and how well participants stick with the program.

What this could mean

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

Active substance
supervised physical activity program (aerobic, anaerobic, and mind-body exercises like yoga)
What this could lead to
If it works, this could point toward a non-drug way to improve sleep for people recovering from alcohol use disorder.
What could go wrong
This is a small, early feasibility study with only 40 participants, so results may not apply to everyone. The program requires time and commitment, and some may not stick with it.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

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 65 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: * Subjects aged 18 to 65 years inclusive * Present an Alcohol Use Disorder (AUD) with at least 2 positive items as defined by the DSM-5 * Present a sleep complaint with a score on the Pittsburgh Sleep Quality Index (PSQI) ≥ 5 * Present active alcohol consumption with at least 6 days of excessive alcohol consumption in the last 4 weeks * Speak and understand French * Live within 30 minutes of the University Hospital of Besançon * Treatment allowed if stabilized for at least 4 weeks * Signature of informed consent indicating that the subject has understood the purpose and procedures required by the study and agrees to participate and comply with the requirements and restrictions inherent to the study * Signed automobile safety contract: 1. The participant agrees to hand over the keys to their vehicle if necessary. 2. The keys will be returned when the blood alcohol level is below 0.25 mg/L 3. The participant agrees to name one or more people to contact in case the medical staff deems the participant unfit to return home alone. * Affiliation to a French social security system or beneficiary of such a system * Postmenopausal women for at least 24 months, surgically sterilized, or, for women of childbearing age, using an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches) (self-reported) Exclusion Criteria: * Decompensated heart failure * Complex ventricular arrhythmias * Severe uncontrolled hypertension * Pulmonary hypertension (\>60 mmHg) * Myocarditis or acute pericardial effusion * Severe obstructive cardiomyopathy * Severe and/or symptomatic aortic stenosis * All acute illnesses * All decompensated or unstable chronic conditions * Significant malnutrition * Extreme fatigue and/or manifest physical incapacity * Severe anemia * Severe intoxication (psychoactive substances) * Severe withdrawal syndrome (Cushman \>7) * Relative contraindications for high-intensity physical activities: * Chronic respiratory insufficiency on long-term oxygen * Severe chronic respiratory conditions * Complicated diabetes with severe retinopathy * Sickle cell disease * Mild intoxication (psychoactive substances) * Mild withdrawal syndrome (Cushman \>2) * Musculoskeletal and dermatological limitations: Unhealed traumatic injuries. * Musculoskeletal and dermatological limitations: Osteoarticular conditions in acute flare (osteoarthritis, arthritis). * Musculoskeletal and dermatological limitations: Diabetes with plantar ulcer. * Musculoskeletal and dermatological limitations: Pressure ulcers and evolving or chronic wounds. * On the day of signing consent: Blood alcohol concentration \> 0 mg/L of expired air. * On the day of signing consent: If blood alcohol concentration is \< 0.25 mg/L, the participant may join other therapeutic activities and return home autonomously. * On the day of signing consent: If blood alcohol concentration is \> 0.25 mg/L without clinical signs of intoxication, the participant may join other therapeutic activities and return home accompanied. * On the day of signing consent: If blood alcohol concentration is \> 0.25 mg/L with clinical signs of intoxication, the participant will not join other therapeutic activities. A supervised room placement will be offered, and emergency services may be contacted if intoxication is unusually high (\>2 g/L). * Excessive alcohol consumption ≥ 6 days in the 4 weeks prior to inclusion. * Average alcohol consumption \> 20 g/day or \> 100 g/week. * CIWA score ≥ 9, indicating the need for medication-assisted withdrawal. * High physical activity levels according to the Global Physical Activity Questionnaire (GPAQ). * Concurrent treatment with disulfiram, melatonin, and beta-blockers. * Unstable or recently changed treatments (\<4 weeks). * History of pre-delirium tremens or delirium tremens. * Substance use disorder (other than alcohol/nicotine per DSM-5). * Acute psychiatric disorders requiring immediate hospitalization or adjustment of psychotropic medications. * Advanced somatic disorders contraindicating physical activity. * Lack of signed automobile safety contract. * Legal incapacity or refusal to sign consent. * No health insurance. * Anticipated poor cooperation or difficulty completing the study * Pregnant or breastfeeding women. * Currently in the exclusion period of another study or listed in the national volunteer registry.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • CHU de Besançon

    RECRUITING

    Besançon, 25000, France

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