About this trial
The primary objective of the SLEEPLAY study is to assess the feasibility of a research protocol investigating the impact of video games on sleep in adults. More specifically, this study aims to identify potential barriers, facilitators of participation, and participant adherence to various measurement tools (such as actigraphy and melatonin assays) to validate the protocol for a larger future study. Additionally, it seeks to optimize the recruitment of regular adult gamers and determine the conditions that will enable better collection of objective sleep data. The relevance of this feasibility study lies in its ability to test and refine the methodology, thereby facilitating future research while minimizing costs and implementation time.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women and men aged 18 to 40
Signed informed consent form
For regular gamers: playing video games at least 3 times a week in the past 2 years, with IGDT-10 (Ten-Item Internet Gaming Disorder Test) > 5
For control group: non-player or occasional player (at least once in the previous year, but less than once a month)
Disqualifiers
Night worker
WIth treatment for sleep disorder or interfering with melatonin secretion (betablokers, melatonin supplements,some antidepressants)
Any pathology leading to circadian rythm disorder, neurological or psychiatric disorder
major addiction (any game or gambling disorder) except for coffee and tabacco
Trial design
Parallel
Treatments tested in this trial
Sleep Assessment Protocol
BehavioralParticipants will engage in a structured protocol to assess sleep patterns and potential disturbances related to video game usage. This protocol includes: * Completion of diaries: Participants will maintain a sleep diary, video game usage diary, and screen time diary for 14 days to record their activities and sleep quality. * Clinical assessments: At Visit 2, participants will complete questionnaires related to sleep quality and disturbances, administered by a sleep specialist neurologist. * Actigraphy monitoring: Participants will wear an actimeter during the 14-day recording period to objectively measure sleep activity. * Biological sampling: After the 14 days, participants will provide urinary samples for analysis of 6-sulfatoxymelatonin to evaluate melatonin levels.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Capacity
Number of participants successfully included in the study per month within each group (Regular Gamers and Non-Gamers).
Attrition rate
Percentage of participants who drop out of the study.
Data Completeness
Mean number of days with valid data for: sleep diary, video game and screen-use diary, actigraphy (≥90% wear time), urinary samples for 6-sulfatoxymelatonin
Acceptability
Proportion of subjects who accepted to participate in the study compared to the number of eligible patients contacted.
Secondary outcomes
Average Sleep Onset Latency
Duration between going to bed and falling asleep, expressed in minutes (average calculated over 14 days)
Total Sleep Time (minutes) measured by wrist actigraphy.
Total nightly sleep duration estimated objectively using actigraphy.
Sleep Onset Latency (minutes) from daily sleep diary.
Time between lying down and perceived sleep onset, self-reported each morning.
Sleep Efficiency (Actigraphy)
Sleep Efficiency (%) measured by actigraphy.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de Besancon
Lead sponsor
Association Le Don du Souffle
Collaborator