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NCT Number: NCT07411404

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

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.

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Key information

Conditions

Sleep Video Gamers

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon

Besançon, 25000, France

Location status: Recruiting

Location contact

Karine Charrière, PhD

CONTACT

[email protected]

0381218999

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Capacity

    Time frame: Month 20 of the study

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

  2. Attrition rate

    Time frame: Month 21 at the end of the study

    Percentage of participants who drop out of the study.

  3. Data Completeness

    Time frame: Month 21 at the end of the study

    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

  4. Acceptability

    Time frame: Month 20 of the study

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

Secondary outcomes

  1. Average Sleep Onset Latency

    Time frame: Month 1

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

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

    Time frame: Up to Day 25 post-inclusion

    Total nightly sleep duration estimated objectively using actigraphy.

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

    Time frame: Up to Day 25 post-inclusion

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

  4. Sleep Efficiency (Actigraphy)

    Time frame: Up to Day 25 post-inclusion

    Sleep Efficiency (%) measured by actigraphy.

  5. Circadian Phase Marker - 6-SMT Acrophase

    Time frame: Up to Day 25 post-inclusion

    6-sulfatoxymelatonin acrophase (clock time, hh:mm).

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Up to Day 25 post-inclusion

    Global sleep quality score from the Pittsburgh Sleep Quality Index, ranging from 0 to 21; higher scores indicate poorer sleep quality (i.e. worse sleep quality)

  7. Insomnia Severity Index (ISI)

    Time frame: Up to Day 25 post-inclusion

    Insomnia severity index (ISI) total score, ranging from 0 to 28; higher scores indicate more severe insomnia symptoms (i.e.worse insomnia severity)

  8. Morningness-Eveningness Questionnaire (MEQ)

    Time frame: Up to Day 25 post-inclusion

    Morningness-Eveningness Questionnaire (MEQ) total score (self-reported measure, ranging from 16 to 86). Chronotype score; higher scores indicate stronger morningness preference.

Study contacts

Contact information is provided by the study sponsor or research team.

Karine CHARRIERE, PhD

CONTACT

[email protected]

+3367840302

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Association Le Don du Souffle

Registry information

Acronym: SLEEPLAY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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