Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCentre Hospitalier Universitaire de Besancon

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sleep Assessment Protocol

    Behavioral

    Participants 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

40 Participants
are divided into 2 treatment groups
Group A: Regular GamersExperimental treatment 1 intervention
Group B: Non-gamersActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Capacity

Number of participants successfully included in the study per month within each group (Regular Gamers and Non-Gamers).

Time frame
Month 20 of the study
2

Attrition rate

Percentage of participants who drop out of the study.

Time frame
Month 21 at the end of the study
3

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

Time frame
Month 21 at the end of the study
4

Acceptability

Proportion of subjects who accepted to participate in the study compared to the number of eligible patients contacted.

Time frame
Month 20 of the study

Secondary outcomes

1

Average Sleep Onset Latency

Duration between going to bed and falling asleep, expressed in minutes (average calculated over 14 days)

Time frame
Month 1
2

Total Sleep Time (minutes) measured by wrist actigraphy.

Total nightly sleep duration estimated objectively using actigraphy.

Time frame
Up to Day 25 post-inclusion
3

Sleep Onset Latency (minutes) from daily sleep diary.

Time between lying down and perceived sleep onset, self-reported each morning.

Time frame
Up to Day 25 post-inclusion
4

Sleep Efficiency (Actigraphy)

Sleep Efficiency (%) measured by actigraphy.

Time frame
Up to Day 25 post-inclusion

Other outcomes

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