Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-01 @ 11:14 PM
Study NCT ID:
NCT06555666
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2021-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice (Plongée Santé)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'injury during diving practice since the consultation', 'timeFrame': '1 month', 'description': 'type and number of diving injury'}], 'secondaryOutcomes': [{'measure': 'evolution of health status', 'timeFrame': '1 month', 'description': 'qualitative scale : new pathology, worse, stable or better'}, {'measure': 'evolution of the chronic pathology', 'timeFrame': '1 month', 'description': 'qualitative scale : worse, stable, recurrence or remission'}, {'measure': 'duration of physical or sport practice per week', 'timeFrame': '1 month', 'description': 'in hours per week'}, {'measure': 'medical recommendation respect', 'timeFrame': '1 month', 'description': 'for each participant, comparison between the medical recommended practice framework and the actual practice declared; then percentage of participant that indicate following the medical recommendation'}, {'measure': 'number of dives carried out since the consultation', 'timeFrame': '1 month', 'description': 'average number per year of practice'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['scuba diving', 'medical fitness', 'sport for health'], 'conditions': ['Diving Barotrauma']}, 'descriptionModule': {'briefSummary': 'The study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the Brest University Hospital. These people may have no health problem or on the contrary consult because they have a pathology and want a medical advice on the impact of this health problem on their practice: this is the case for about the half of these consultants.\n\nFor the latter, there are no data concerning the relevance of a medical advice response and a proposal for an appropriate technical practice framework (restriction of dive depth, duration, etc.). A relevant answer results in a practice without diving accidents or decompensation of the pathology and a decision accepted and respected by the practitioner.\n\nThis study aims to analyze the state of health of the service\'s consultants and medical recommendations formulated at the end of this consultation, by retrospective analysis of the consultation files, and to interview the consultants on their practice of diving, their state of health and any problems encountered since their consultation.\n\nThe purpose is to validate the hypothesis that a practice of underwater diving is possible and beneficial, with an acceptable risk in case of a risk factor or pathology using a framework of advice and restrictions of adapted and individualized practice ("sport for health").', 'detailedDescription': 'This is a single-center retrospective study on health data. The methodology includes a collection of data on health and practice of scuba diving, figuring on the medical consultation files and then carrying out a telephone interview of people seen in diving medicine consultation between 01/01/2015 and on 12/31/2018 in the hyperbaric and underwater medicine department of the Brest University hospital.\n\nOne month before the start of these interviews, an information letter on the study is sent by post, giving the possibility of opposing it.\n\nThe main evaluation criteria are the number of dives carried out since the consultation (and the average number of dives per year of practice), and the number of accidents or incidents during the practice of recreational scuba diving in the framework proposed, during the months or years following the medical consultation The secondary evaluation criteria are the evolution of the chronic pathology, the evolution of health status in general, the number of hours of practice of a physical and sport activity per week, the respect of the technical practice framework recommended.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population include new potential divers and confirmed divers who asked for a medical advice about their practice of diving.\n\nAbout a half of this population have had a diving injury or has a chronic pathology.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People who asked for a medical advice for the diving practice in a consultation in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2018/12/31\n\nExclusion Criteria:\n\n* refusal'}, 'identificationModule': {'nctId': 'NCT06555666', 'acronym': 'Healthy-diving', 'briefTitle': 'Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice (Plongée Santé)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice', 'orgStudyIdInfo': {'id': '29BRC21.0226 - Healthy diving'}}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': 'Anne HENCKES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Brest'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three months and ending five years following the publication', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}