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

NCT07411404 | Recruiting

• 2 other identifiers: 2025/9372025-A00464-45
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep; Video Gamers

Outcome Measures

Primary Outcomes (4)

• Recruitment Capacity

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

  Month 20 of the study

• Attrition rate

  Percentage of participants who drop out of the study.

  Month 21 at the end 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

  Month 21 at the end of the study

• Acceptability

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

  Month 20 of the study

Secondary Outcomes (8)

• Average Sleep Onset Latency

  Month 1

• Total Sleep Time (minutes) measured by wrist actigraphy.

  Up to Day 25 post-inclusion

• Sleep Onset Latency (minutes) from daily sleep diary.

  Up to Day 25 post-inclusion

• Sleep Efficiency (Actigraphy)

  Up to Day 25 post-inclusion

• Circadian Phase Marker - 6-SMT Acrophase

  Up to Day 25 post-inclusion

Study Arms (2)

Regular Gamers

EXPERIMENTAL

Participants who play video games at least 3 times per week for a minimum of 2 years, with an IGDT-10 score of less than 5.

Behavioral: Sleep Assessment Protocol

Non-gamers

ACTIVE COMPARATOR

Participants who do not play video games regularly or play only experimentally (once in their lifetime) or occasionally (at least once a year and less than once a month).

Behavioral: Sleep Assessment Protocol

Interventions

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.

Non-gamers; Regular Gamers

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Association Le Don du Souffle: collaborator

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

Study Officials

• Silvio GALLI, MD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine CHARRIERE, PhD

CONTACT

+3367840302; kcharriere@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: February 13, 2026
• Study Start: September 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)