Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:25 AM
Study NCT ID:
NCT07411404
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Capacity', 'timeFrame': 'Month 20 of the study', 'description': 'Number of participants successfully included in the study per month within each group (Regular Gamers and Non-Gamers).'}, {'measure': 'Attrition rate', 'timeFrame': 'Month 21 at the end of the study', 'description': 'Percentage of participants who drop out of the study.'}, {'measure': 'Data Completeness', 'timeFrame': 'Month 21 at the end of the study', 'description': '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'}, {'measure': 'Acceptability', 'timeFrame': 'Month 20 of the study', 'description': 'Proportion of subjects who accepted to participate in the study compared to the number of eligible patients contacted.'}], 'secondaryOutcomes': [{'measure': 'Average Sleep Onset Latency', 'timeFrame': 'Month 1', 'description': 'Duration between going to bed and falling asleep, expressed in minutes (average calculated over 14 days)'}, {'measure': 'Total Sleep Time (minutes) measured by wrist actigraphy.', 'timeFrame': 'Up to Day 25 post-inclusion', 'description': 'Total nightly sleep duration estimated objectively using actigraphy.'}, {'measure': 'Sleep Onset Latency (minutes) from daily sleep diary.', 'timeFrame': 'Up to Day 25 post-inclusion', 'description': 'Time between lying down and perceived sleep onset, self-reported each morning.'}, {'measure': 'Sleep Efficiency (Actigraphy)', 'timeFrame': 'Up to Day 25 post-inclusion', 'description': 'Sleep Efficiency (%) measured by actigraphy.'}, {'measure': 'Circadian Phase Marker - 6-SMT Acrophase', 'timeFrame': 'Up to Day 25 post-inclusion', 'description': '6-sulfatoxymelatonin acrophase (clock time, hh:mm).'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Up to Day 25 post-inclusion', 'description': 'Global sleep quality score from the Pittsburgh Sleep Quality Index; higher scores indicate poorer sleep quality.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'Up to Day 25 post-inclusion', 'description': 'Insomnia severity score; higher scores indicate more severe insomnia symptoms.'}, {'measure': 'Morningness-Eveningness Questionnaire (MEQ)', 'timeFrame': 'Up to Day 25 post-inclusion', 'description': 'MEQ total score (16-86). Chronotype score; higher scores indicate stronger morningness preference.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Video Gamers']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women and men aged 18 to 40\n* Signed informed consent form\n* 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\n* For control group: non-player or occasional player (at least once in the previous year, but less than once a month)\n\nExclusion Criteria:\n\n* Night worker\n* WIth treatment for sleep disorder or interfering with melatonin secretion (betablokers, melatonin supplements,some antidepressants)\n* Any pathology leading to circadian rythm disorder, neurological or psychiatric disorder\n* major addiction (any game or gambling disorder) except for coffee and tabacco'}, 'identificationModule': {'nctId': 'NCT07411404', 'acronym': 'SLEEPLAY', 'briefTitle': 'Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study', 'orgStudyIdInfo': {'id': '2025/937'}, 'secondaryIdInfos': [{'id': '2025-A00464-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regular Gamers', 'description': '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.', 'interventionNames': ['Behavioral: Sleep Assessment Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-gamers', 'description': '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).', 'interventionNames': ['Behavioral: Sleep Assessment Protocol']}], 'interventions': [{'name': 'Sleep Assessment Protocol', 'type': 'BEHAVIORAL', 'description': 'Participants will engage in a structured protocol to assess sleep patterns and potential disturbances related to video game usage. This protocol includes:\n\n* 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.\n* Clinical assessments: At Visit 2, participants will complete questionnaires related to sleep quality and disturbances, administered by a sleep specialist neurologist.\n* Actigraphy monitoring: Participants will wear an actimeter during the 14-day recording period to objectively measure sleep activity.\n* Biological sampling: After the 14 days, participants will provide urinary samples for analysis of 6-sulfatoxymelatonin to evaluate melatonin levels.', 'armGroupLabels': ['Non-gamers', 'Regular Gamers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine Charrière, PhD', 'role': 'CONTACT', 'email': 'kcharriere@chu-besancon.fr', 'phone': '0381218999'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Karine CHARRIERE, PhD', 'role': 'CONTACT', 'email': 'kcharriere@chu-besancon.fr', 'phone': '+3367840302'}], 'overallOfficials': [{'name': 'Silvio GALLI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association Le Don du Souffle', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}