Actively Recruiting
Effect of Adapted Physical Activity on Sleep Quality in People With Alcohol Use Disorder
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2026-02-12
40
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This feasibility study aims to assess interest, recruitment, and adherence to a supervised physical activity (APA) program among individuals with Alcohol Use Disorder (AUD). It also investigates the program's impact on sleep quality and efficiency. Key objectives include evaluating recruitment feasibility, assessing randomization acceptance, quantifying adherence rates, and identifying sensitive sleep assessment tools. The study will explore whether APA improves sleep outcomes in AUD patients with sleep complaints, laying groundwork for larger-scale research. Participants will engage in APA sessions, complete sleep assessments (including sleep diaries and psychometric scales), and provide sociodemographic data and past activity adherence.
CONDITIONS
Official Title
Effect of Adapted Physical Activity on Sleep Quality in People With Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years inclusive
- Diagnosed Alcohol Use Disorder with at least 2 positive DSM-5 items
- Sleep complaint with Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher
- Active alcohol consumption with at least 6 days of excessive drinking in the last 4 weeks
- Ability to speak and understand French
- Living within 30 minutes of the University Hospital of Besançon
- Stable treatment for at least 4 weeks if receiving treatment
- Signed informed consent indicating understanding and agreement to participate
- Signed automobile safety contract agreeing to hand over vehicle keys if necessary, with return conditions and naming emergency contacts
- Affiliation with French social security or beneficiary status
- For women: postmenopausal for at least 24 months, surgically sterilized, or using effective contraception if of childbearing age (self-reported)
You will not qualify if you...
- Decompensated heart failure
- Complex ventricular arrhythmias
- Severe uncontrolled hypertension
- Pulmonary hypertension over 60 mmHg
- Myocarditis or acute pericardial effusion
- Severe obstructive cardiomyopathy
- Severe or symptomatic aortic stenosis
- Any acute illness
- Decompensated or unstable chronic conditions
- Significant malnutrition
- Extreme fatigue or physical incapacity
- Severe anemia
- Severe intoxication with psychoactive substances
- Severe withdrawal syndrome (Cushman score >7)
- Relative contraindications to high-intensity physical activity including chronic respiratory insufficiency on long-term oxygen, severe chronic respiratory conditions, complicated diabetes with severe retinopathy, sickle cell disease
- Mild intoxication or mild withdrawal syndrome (Cushman score >2)
- Musculoskeletal or dermatological limitations such as unhealed traumatic injuries, acute osteoarticular flare, diabetes with plantar ulcer, pressure ulcers or chronic wounds
- Blood alcohol concentration >0 mg/L on day of consent signing
- Excessive alcohol consumption ≥6 days in 4 weeks prior to inclusion
- Average alcohol consumption >20 g/day or >100 g/week
- CIWA score ≥9 requiring medication-assisted withdrawal
- High physical activity levels per Global Physical Activity Questionnaire (GPAQ)
- Concurrent treatment with disulfiram, melatonin, or beta-blockers
- Unstable or recently changed treatments under 4 weeks
- History of pre-delirium tremens or delirium tremens
- Substance use disorder other than alcohol or nicotine
- Acute psychiatric disorders needing immediate hospitalization or medication adjustment
- 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 exclusion period of another study or listed in national volunteer registry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Besançon
Besançon, France, 25000
Actively Recruiting
Research Team
K
Karine CHARRIERE, PhD
CONTACT
M
Magali NICOLIER, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here