Effect of Adapted Physical Activity on Sleep Quality in People With Alcohol Use Disorder

Recruiting now · Not applicable

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT06706349

Run by

Centre Hospitalier Universitaire de Besancon

People needed

40

Starts

2024-10-17

Expected to finish

2027-10-01

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• The participant agrees to hand over the keys to their vehicle if necessary.
• The keys will be returned when the blood alcohol level is below 0.25 mg/L
• 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)

You may not qualify if…

• 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.

Where it is running

• CHU de Besançon — Besançon, France (enrolling)

Full record on ClinicalTrials.gov

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