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Recruiting NCT07411404

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

No phase Interventional Sleep Video Gamers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep Assessment Protocol.
Who it may be relevant to
Registry conditions: Sleep, Video Gamers. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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. * Ac

Primary outcome measures

  • Recruitment Capacity [Time frame: Month 20 of the study]
  • Attrition rate [Time frame: Month 21 at the end of the study]
  • Data Completeness [Time frame: Month 21 at the end of the study]
  • Acceptability [Time frame: Month 20 of the study]
Secondary outcome measures (8)
  • Average Sleep Onset Latency [Time frame: Month 1]
  • Total Sleep Time (minutes) measured by wrist actigraphy. [Time frame: Up to Day 25 post-inclusion]
  • Sleep Onset Latency (minutes) from daily sleep diary. [Time frame: Up to Day 25 post-inclusion]
  • Sleep Efficiency (Actigraphy) [Time frame: Up to Day 25 post-inclusion]
  • Circadian Phase Marker - 6-SMT Acrophase [Time frame: Up to Day 25 post-inclusion]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Up to Day 25 post-inclusion]
  • Insomnia Severity Index (ISI) [Time frame: Up to Day 25 post-inclusion]
  • Morningness-Eveningness Questionnaire (MEQ) [Time frame: Up to Day 25 post-inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Besançon — Besançon

Identifiers

NCT: NCT07411404 · 2025/937 · 2025-A00464-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗