Impact of physical activity on sleep quality for people with alcohol use disorder

Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder

This study is testing whether a supervised exercise program can help improve sleep quality for people struggling with alcohol use disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Besancon (Academic / other)
• Locations: 1 site (Besançon)
• Trial ID: NCT06706349 on ClinicalTrials.gov

What this trial studies

This feasibility study evaluates the interest, recruitment, and adherence to a supervised physical activity program among individuals with Alcohol Use Disorder (AUD). It aims to assess the program's effects on sleep quality and efficiency, focusing on recruitment feasibility, randomization acceptance, and adherence rates. Participants will engage in adapted physical activity sessions and complete various sleep assessments, including sleep diaries and psychometric scales, to determine the potential benefits of physical activity on sleep outcomes in AUD patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of Alcohol Use Disorder and sleep complaints.

Not a fit: Patients who do not have sleep complaints or are not actively consuming alcohol may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve sleep quality for individuals suffering from Alcohol Use Disorder.

How similar studies have performed: While this approach is novel in the context of AUD, similar studies have shown that physical activity can positively impact sleep quality in various populations.

Eligibility criteria

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.

Where this trial is running

Besançon

• CHU de Besançon — Besançon, France (Recruiting)

Study contacts

• Principal investigator: Julie GIUSTINIANI, MD — CHU Besançon
• Study coordinator: Karine CHARRIERE, PhD

Conditions Alcohol Use Disorder