RecruitingNot Applicable

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

France40 participantsStarted 2024-10-17

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Sleep duration measured by actigraphy.

Timeframe: Baseline, 6 weeks (midpoint), 12 weeks (end of sessions), and 14 weeks (2 weeks post-intervention)

Circadian parameters measured by urinary melatonin levels.

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks

Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Insomnia severity measured by Insomnia Severity Index (ISI).

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS).

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Sleep-wake patterns measured by sleep diary.

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Morningness-eveningness preferences measured by Horne and Östberg Scale.

Timeframe: Baseline only.

Trial details

NCT IDNCT06706349

SponsorCentre Hospitalier Universitaire de Besancon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Karine CHARRIERE, PhD

+ 33381218999 kcharriere@chu-besancon.fr

View on ClinicalTrials.gov More Alcohol Use Disorder trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Sleep duration measured by actigraphy.

Timeframe: Baseline, 6 weeks (midpoint), 12 weeks (end of sessions), and 14 weeks (2 weeks post-intervention)

Circadian parameters measured by urinary melatonin levels.

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks

Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Insomnia severity measured by Insomnia Severity Index (ISI).

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS).

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Sleep-wake patterns measured by sleep diary.

Timeframe: Baseline, 6 weeks, 12 weeks, and 14 weeks.

Morningness-eveningness preferences measured by Horne and Östberg Scale.

Timeframe: Baseline only.