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

July 20, 2026 updated by: Centre Hospitalier Universitaire de Besancon
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Month 20 of the study
Attrition rate
Time Frame: Month 21 at the end of the study
Percentage of participants who drop out of the study.
Month 21 at the end of the study
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
Month 21 at the end of the study
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.
Month 20 of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average Sleep Onset Latency
Time Frame: Month 1
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.
Time Frame: Up to Day 25 post-inclusion
Total nightly sleep duration estimated objectively using actigraphy.
Up to Day 25 post-inclusion
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.
Up to Day 25 post-inclusion
Sleep Efficiency (Actigraphy)
Time Frame: Up to Day 25 post-inclusion
Sleep Efficiency (%) measured by actigraphy.
Up to Day 25 post-inclusion
Circadian Phase Marker - 6-SMT Acrophase
Time Frame: Up to Day 25 post-inclusion
6-sulfatoxymelatonin acrophase (clock time, hh:mm).
Up to Day 25 post-inclusion
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)
Up to Day 25 post-inclusion
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)
Up to Day 25 post-inclusion
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.
Up to Day 25 post-inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Besancon

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Association Le Don du Souffle

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvio GALLI, MD, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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