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 range

18 Years – 65 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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.

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 range

18 Years – 65 Years

Sex

ALL

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.