Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment Capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sleep Assessment Protocol (Behavioral)
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).
干预措施: Sleep Assessment Protocol (Behavioral)
结局指标
主要结局
Recruitment Capacity
时间窗: Month 20 of the study
Number of participants successfully included in the study per month within each group (Regular Gamers and Non-Gamers).
Attrition rate
时间窗: Month 21 at the end of the study
Percentage of participants who drop out of the study.
Data Completeness
时间窗: 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
Acceptability
时间窗: Month 20 of the study
Proportion of subjects who accepted to participate in the study compared to the number of eligible patients contacted.
次要结局
- Morningness-Eveningness Questionnaire (MEQ)(Up to Day 25 post-inclusion)
- 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)
- Pittsburgh Sleep Quality Index (PSQI)(Up to Day 25 post-inclusion)
- Insomnia Severity Index (ISI)(Up to Day 25 post-inclusion)