SleepSLEEPLAYNCT07411404
Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study
A study testing Sleep Assessment Protocol in people with Sleep and Video Gamers, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Video Gamers
- What is being tested?
- Sleep Assessment Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Karine Charrière, PhD, 0381218999, kcharriere@chu-besancon.fr
About this 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.
- Conditions
- Sleep, Video Gamers
- Being tested
- Sleep Assessment Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Assessment ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Assessment Protocol |
| 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). Receives: Behavioral: Sleep Assessment Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Capacity
Number of participants successfully included in the study per month within each group (Regular Gamers and Non-Gamers).
Measured: Month 20 of the study
Attrition rate
Percentage of participants who drop out of the study.
Measured: 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
Measured: 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.
Measured: Month 20 of the study
Secondary outcomes (8)
Average Sleep Onset Latency
Duration between going to bed and falling asleep, expressed in minutes (average calculated over 14 days)
Measured: Month 1
Total Sleep Time (minutes) measured by wrist actigraphy.
Total nightly sleep duration estimated objectively using actigraphy.
Measured: 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.
Measured: Up to Day 25 post-inclusion
Sleep Efficiency (Actigraphy)
Sleep Efficiency (%) measured by actigraphy.
Measured: Up to Day 25 post-inclusion
Circadian Phase Marker - 6-SMT Acrophase
6-sulfatoxymelatonin acrophase (clock time, hh:mm).
Measured: Up to Day 25 post-inclusion
Pittsburgh Sleep Quality Index (PSQI)
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)
Measured: Up to Day 25 post-inclusion
Insomnia Severity Index (ISI)
Insomnia severity index (ISI) total score, ranging from 0 to 28; higher scores indicate more severe insomnia symptoms (i.e.worse insomnia severity)
Measured: Up to Day 25 post-inclusion
Morningness-Eveningness Questionnaire (MEQ)
Morningness-Eveningness Questionnaire (MEQ) total score (self-reported measure, ranging from 16 to 86). Chronotype score; higher scores indicate stronger morningness preference.
Measured: Up to Day 25 post-inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Dec 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Association Le Don du Souffle
- Responsible party
- Sponsor
- Investigators
- Silvio GALLI, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411404
- Sponsor's protocol ID
- 2025/937
- Other IDs
- 2025-A00464-45
- Acronym
- SLEEPLAY
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study
- ClinicalTrials.gov ID
- NCT07411404
- Acronym / sponsor ID
- SLEEPLAY / 2025/937
- Conditions
- Sleep, Video Gamers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Association Le Don du Souffle
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Gamers | Experimental | Behavioral: Sleep Assessment ProtocolParticipants 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. |
| Non-gamers | Active comparator | Behavioral: Sleep Assessment ProtocolParticipants 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Assessment ProtocolParticipants 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. | Behavioural | Non-gamers, Regular Gamers |
Primary outcome
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).
Attrition rate
Time frame: Month 21 at the end of the study
Percentage of participants who drop out 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
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvio GALLI, MD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Assessment Protocol in people with Sleep and Video Gamers, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine CHARRIERE, PhD (+3367840302, kcharriere@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Capacity (time frame: Month 20 of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.