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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Video Gamers
• Intervention / Treatment: Behavioral: Sleep Assessment Protocol

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karine CHARRIERE, PhD; Phone Number: +3367840302; Email: kcharriere@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU de Besancon
    • Contact: Karine Charrière, PhD; Phone Number: 0381218999; Email: kcharriere@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regular Gamers; 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; 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.
Active Comparator: Non-gamers; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Sleep Onset Latency	Duration between going to bed and falling asleep, expressed in minutes (average calculated over 14 days)	Month 1
Total Sleep Time (minutes) measured by wrist actigraphy.	Total nightly sleep duration estimated objectively using actigraphy.	Up to Day 25 post-inclusion
Sleep Onset Latency (minutes) from daily sleep diary.	Time between lying down and perceived sleep onset, self-reported each morning.	Up to Day 25 post-inclusion
Sleep Efficiency (Actigraphy)	Sleep Efficiency (%) measured by actigraphy.	Up to Day 25 post-inclusion
Circadian Phase Marker - 6-SMT Acrophase	6-sulfatoxymelatonin acrophase (clock time, hh:mm).	Up to Day 25 post-inclusion
Pittsburgh Sleep Quality Index (PSQI)	Global sleep quality score from the Pittsburgh Sleep Quality Index; higher scores indicate poorer sleep quality.	Up to Day 25 post-inclusion
Insomnia Severity Index (ISI)	Insomnia severity score; higher scores indicate more severe insomnia symptoms.	Up to Day 25 post-inclusion
Morningness-Eveningness Questionnaire (MEQ)	MEQ total score (16-86). Chronotype score; higher scores indicate stronger morningness preference.	Up to Day 25 post-inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Association Le Don du Souffle
• Investigators: Principal Investigator: Silvio GALLI, MD, CHU de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025/937; 2025-A00464-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No