Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05618405
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in Circadian Rhythm After Anaesthesia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020178', 'term': 'Sleep Disorders, Circadian Rhythm'}, {'id': 'D020179', 'term': 'Jet Lag Syndrome'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000076082', 'term': 'Travel-Related Illness'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-11-11', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diurnal phase shift', 'timeFrame': 'Baseline (1wk before anesthesia) - First night post-anesthesia', 'description': 'The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.'}], 'secondaryOutcomes': [{'measure': 'Change in sleep quality', 'timeFrame': '3 days pre-anaesthesia - 7 days post-anaesthesia', 'description': "The change in subjective sleep quality, including incidence of sleep problems (e.g. sleepwalking, nightmares), as measured by the Children's Sleep Habits Questionnaire (CSHQ), between the month prior to 3 nights pre-anesthesia and 1 week post-anesthesia. This is measured on a likert scale 1 meaning no sleep problems and 5 meaning a lot of sleep problems. The answers from questionnaire 1 (3 days preoperative) are compared to answers of questionnaire 2 (7 days postoperative)"}, {'measure': 'Changes in all sleep times', 'timeFrame': '3 days pre-anaesthesia - 7 days post-anaesthesia', 'description': "Changes in all sleep parameters (i.e. sleep on- and offset times, sleep duration, sleep latency) when comparing baseline (as measured by the Children's ChronoType Questionnaire (CCTQ) 3 days pre-anesthesia) to all 10 nights of the sleeping log."}, {'measure': 'Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery', 'timeFrame': '3 days pre-anaesthesia - 7 days post-anaesthesia', 'description': 'Difference in subjective sleep quality (as measured by the CSHQ) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure. Answers are on a likerts scale with 1 meaning no sleep problems and 5 meaning a lot of sleep problems.'}, {'measure': 'Difference in sleep-wake timing', 'timeFrame': '3 days pre-anaesthesia - 7 days post-anaesthesia', 'description': 'Difference in changes in sleep-wake timing (as measured by the sleeping log, units are minutes) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Circadian Rhythm Sleep Disorder', 'Circadian Rhythm Disorder Caused by Drug', 'Circadian Rhythm Sleep Disorder, Jet Lag Type', 'Jet Lag', 'Anesthesia', 'Sleep', 'Sleep Disorders, Circadian Rhythm', 'Sleep Disturbance']}, 'descriptionModule': {'briefSummary': 'In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary.', 'detailedDescription': "Objective:\n\nThe primary objective is to assess the effect of general anaesthesia and surgery on sleep duration (chronotype) and sleep quality in children aged 1-11 years in the first week after surgery.\n\nSecondary objectives are to determine the duration of the effect of general anaesthesia on chronotype and sleep quality. Furthermore, the investigators will examine factors which may be of influence on the quality and duration of sleep, like postoperative emergence delirium, admission to the hospital, Face, Legs, Activity, Cry, Consolability scale (FLACC) / Numeric Rating Scale (NRS) scores, preoperative sedative medication and postoperative sedative medication.\n\nStudy procedures:\n\nPossible participants will be identified on the anaesthetic pre-operative assessment clinic and asked if they object to a phone call with information about research. If not, a researcher will contact the parents by telephone to inform them about the study. After oral consent by both parents, an invitation to fill in the questionnaires will be sent to the parents together with a consent form. Informed consent by both parents will be obtained. Questionnaires can be completed online or on paper, depending on the parents' preference.\n\nQuestionnaires:\n\n* Sleep quality: Child's Sleep Habits Questionnaire (CSHQ) on day 3 preoperative and on day 7 postoperative.\n* Chronotype: Children's chronotype questionnaire on day 3 preoperative\n* Daily sleep diary starting from 3 days preoperative until 7 days postoperative\n\nThe following items will be extracted from the electronic health record:\n\n* Demographic criteria: age, gender, type of procedure\n* Admission dates\n* Preoperative sedative medication\n* Postoperative sedative medication\n* NRS/FLACC scores during hospital stay All items will be entered in an electronic database (CASTOR)\n\nPrimary endpoint The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.\n\nSecondary endpoints\n\n* Change in sleep quality as measured with the CSHQ questionnaire\n* Incidence of postoperative sleep problems as measured with the CSHQ questionnaire\n* Difference in sleep problems, sleep duration and sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery\n* Influence of pain and sedative medication on sleep duration and quality"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 1-11 years planned for elective surgery or a procedure requiring general anaesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* General anaesthesia for surgery or magnetic resonance imaging (MRI) with a minimal duration of 30 minutes\n* Age 1-11 years\n* Informed consent of both parents\n\nExclusion criteria:\n\n* Parents are not fluent in Dutch\n* Known severe sleep disturbances\n* Postoperative admission to paediatric intensive care unit\n* Moderate to severe developmental disorder (IQ\\<85)\n* American Society of Anesthesiologists (ASA) classification \\> 3'}, 'identificationModule': {'nctId': 'NCT05618405', 'acronym': 'CLOCKSkids', 'briefTitle': 'Changes in Circadian Rhythm After Anaesthesia in Children', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Effect of General Anaesthesia and Surgery on Sleep-wake Timing in Children: the CLOCKS Kids Observational Study', 'orgStudyIdInfo': {'id': 'W22_068'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children who undergo anesthesia because of surgery', 'description': 'Children, aged between 1-11 years, who undergo general anesthesia because of surgery.'}, {'label': 'Children who undergo anesthesia because of an MRI', 'description': 'Children, aged between 1-11 years, who undergo general anesthesia because of an MRI.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, locatie AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Jeroen Hermanides, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pediatric Anesthesiologist, principal investigator', 'investigatorFullName': 'Jorinde Polderman', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}