Sleep Disorders Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People aged 18 to 65 years old
- People who have been assessed as having Alcohol Use Disorder (AUD), meeting at least 2 criteria as defined by a standard diagnostic tool called DSM-5
- People who have sleep problems, scoring 5 or higher on a standard sleep quality questionnaire called the Pittsburgh Sleep Quality Index (PSQI)
- People who have had at least 6 days of excessive alcohol consumption in the last 4 weeks
- People who speak and understand French
- People who live within 30 minutes of the University Hospital of Besançon
- People who are on stable treatments that have not changed for at least 4 weeks
- People who are willing to sign a consent form showing they understand the study and agree to take part
- People who are willing to sign a safety agreement about driving, which includes agreeing to hand over vehicle keys if needed, having keys returned only when breath alcohol is below a safe level, and naming a contact person in case medical staff feel they cannot safely go home alone
- People who are covered by the French social security system
- Women who have been through menopause for at least 24 months, have had surgical sterilisation, or are of childbearing age and using an effective form of contraception (such as the pill, contraceptive injections, an intrauterine device, a double-barrier method, or contraceptive patches)
Who may not be able to join:
- People with heart failure that is not well controlled
- People with serious irregular heart rhythms
- People with severe high blood pressure that is not controlled
- People with high blood pressure in the lungs (above 60 mmHg)
- People with inflammation of the heart muscle or fluid around the heart
- People with a severe condition causing the heart muscle to thicken and obstruct blood flow
- People with severe narrowing of the aortic heart valve, especially if causing symptoms
- People who currently have any acute (sudden or short-term) illness
- People with any chronic condition that is currently unstable or not well managed
- People with significant malnutrition
- People experiencing extreme tiredness or a clear physical inability to exercise
- People with severe anaemia (very low red blood cell levels)
- People who are severely affected by substances other than alcohol at the time of assessment
- People experiencing a severe alcohol withdrawal syndrome (confirmed with trial site using a specific medical score)
- People on long-term oxygen therapy due to chronic breathing problems
- People with severe long-term breathing conditions
- People with diabetes that has caused serious damage to the eyes (severe retinopathy)
- People with sickle cell disease
- People showing mild effects of substances other than alcohol at the time of assessment
- People with mild alcohol withdrawal symptoms (confirmed with trial site)
- People with unhealed injuries affecting muscles, bones, or skin
- People with joints affected by a condition such as osteoarthritis or arthritis that is currently flaring up
- People with diabetes and an active wound on the foot (plantar ulcer)
- People with pressure sores or wounds that are ongoing or not fully healed
- People who have any alcohol in their breath on the day they are asked to sign the consent form
- People whose average alcohol intake exceeds 20 grams per day or 100 grams per week
- People whose alcohol withdrawal score (CIWA) is 9 or above, suggesting they may need medically assisted withdrawal
- People who already do high levels of physical activity, as measured by a standard questionnaire
- People currently taking disulfiram, melatonin, or beta-blocker medications
- People whose medications have changed or are currently unstable within the last 4 weeks
- People who have previously experienced pre-delirium tremens or delirium tremens (serious alcohol withdrawal reactions)
- People who have a substance use disorder involving substances other than alcohol or nicotine, as defined by the DSM-5
- People with acute psychiatric conditions that require immediate hospitalisation or urgent medication changes
- People with advanced physical health conditions that make physical activity unsafe
- People who do not sign the driving safety agreement
- People who are not legally able to give consent, or who decline to sign the consent form
- People without French health insurance
- People who are unlikely to cooperate with or complete the study requirements
- Women who are pregnant or breastfeeding
- People who are currently participating in another clinical study or are listed in the national volunteer registry
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Julie GIUSTINIANI, MD, CHU Besançon
Phone: + 33381218999
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Sleep duration measured by actigraphy.; Circadian parameters measured by urinary melatonin levels.; Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).; Insomnia severity measured by Insomnia Severity Index (ISI).; Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS).; Sleep-wake patterns measured by sleep diary.; Morningness-eveningness preferences measured by Horne and Östberg Scale.; Adherence to treatment measured by completed APA sessions.; Sociodemographic characteristics collected at baseline.; Previous adherence to physical activity.; Dropout rate during intervent...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.