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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00464-45 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Association Le Don du Souffle | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karine CHARRIERE, PhD | Contact | +3367840302 | kcharriere@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Silvio GALLI, MD | CHU de Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Recruiting | Besançon | 25000 | France |
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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 |