Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT06586268
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2024-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The SNORE-trial: Analysis of Alterations in Sleep Stages Following Anesthesia and Their Relation to the Severity of Obstructive Sleep Apnea in the First 3 Nights After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AHI and Desaturations on night one and three after surgery', 'timeFrame': 'from directly post operatively up untill the morning after the third night following surgery.', 'description': 'To compare the AHI and desaturations on night one and night three after surgery'}], 'secondaryOutcomes': [{'measure': 'Desaturations post operatively', 'timeFrame': 'The first six hours after surgery', 'description': 'Assess the amount of patients with na increase of respiratory events (saturation \\<90%) later than 6 hours after surgery.'}, {'measure': 'AHI directly post-operatively', 'timeFrame': 'directly post-operatively up untill the next morning (max 24 hours)', 'description': 'compare the difference between AHI and desaturations in the first six hours after surgery to the first night after surgery.'}, {'measure': 'Changes in total REM sleep', 'timeFrame': 'The first three nights following surgery', 'description': 'Changes in total REM sleep comparing night 1,2 and 3.'}, {'measure': 'Changes in AHI, REM-AHI and desaturations over time', 'timeFrame': 'Night one, two and three.', 'description': 'To analyze the changes over time in AHI, REM-AHI, (respiratory events related tot REM-sleep cycle) and desaturations.'}, {'measure': 'REM sleep and AHI', 'timeFrame': 'From directly post-operatively up untill the morning after the third night.', 'description': 'Correlation between REM Sleep and respiratory events measured as AHI'}, {'measure': 'Comparison of patients with treatment and patients without treatment', 'timeFrame': 'DIrectly post-operatively up untill the morning after night three', 'description': 'Comparing AHI and desaturations between patients with either a MRA or CPAP treatment to those without any form of treatment or other treatment than MRA and CPAP.'}, {'measure': 'Morfine and AHI/desaturations', 'timeFrame': 'from directly post-operatively to the morning after the third night.', 'description': 'Compare respiratory events measured as AHI or desaturations compared to opioid consumption, measured as morphine equivalents.\n\nidentifying different time-frames.\n\n* the first 6 hours after surgery\n* the first night after surgery (excluding the first six hours)\n* night 2 and night 3 after surgery.\n\nalso identifying different modalities if applicable.\n\n* IV (patient controled and nurse controled)\n* oral'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OSAS', 'OSA', 'obstructive sleep apnea', 'Post-surgical', 'post-anesthesia', 'REM sleep', 'PACU', 'AHI', 'Desaturations'], 'conditions': ['Sleep Apnea Syndrome, Obstructive', 'Sleep Apnea Syndrome (OSAS)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the relationship between sleep alterations following anesthesia and their relationship to a potential increase of obstructive sleep apnea (OSA) severity.\n\nOur main question is: Is there an increased severity of OSA on the third post-operative night compared to the first post-operative night and does this have a relation with REM sleep?\n\nParticipants enrolled in this research are all diagnosed with OSA, with or without treament. All participants will be asked to wear a watchlike device called WATCHPAT to identify sleep paterns and register apneic (no breathing) and hypopneic (insufficient breathing) incidents. We ask our participants to wear this device for 8-10 hours a night when they are a sleep.', 'detailedDescription': 'The study is a prospective, observational, single center cohort study on electively scheduled adult surgical patients at the Amsterdam UMC, Amsterdam, The Netherlands.\n\nPatients eligible for inclusion will be identified at the pre-operative screening at the outpatient clinic and contacted and included prior to the day of surgery.\n\nPatients will sign an informed consent. Alternatively patients will be identified by an electronic algoritm which will analyse the next weeks elective surgery list. the algorithm analyzes for sleap apnea; in the patient problem list in their electronic patient file. Patients that have not been identified at the outpatient clinic will be able to be identified as eligible for inclusion via this route.\n\nMeasurement will start post-operatively at the recovery ward. All data will be registered with a non-invasive device, the WatchPAT (ZOLL medical). This device will measure apneic and hypopneic incidents, reported as apneu-hypopneu index (AHI) and vital signs such as blood pressure, heart rate and oxygen saturation. In addition the Watchpat will register REM-sleep via actigrapy. Other patient characteristics and demographics will be retrieved from the electronic patient file (EPIC).\n\nThese measurements will be started within 30 minutes of arriving at the recovery on the day of surgery continuing on into the first night at the PACU unit. On night 2 and 3 post-operatively participants will be asked to wear the device on the ward when going to sleep for the night. measurement period at the ward will be 8-10 hours.\n\nFor results on our primary outcome:\n\ndifference in mean of AHI and desaturations on night one compared to night three.\n\nWe aimed to detect a difference in mean of an AHI of 0.8 in a design with 3 repeated measurements when assuming a standard deviation of 2 and a very conservative between level correlation of 0. In order to detect a similar difference with a power of 80% and a significance level of 0.05, assuming a drop-out rate of 5%, we will need a sample size of 35 patients.\n\nWhen patients are lost to follow up, or have incomplete measurements, defined as no functional data on sleep, AHI and desaturations in night 1 or night 3. Where a sleep time of 1,5 hours a night is minimally needed for complete calculations on AHI.\n\nWe will use descriptive statistics to present the characteristics of patients, using mean with standard deviation, or median with interquartile range for continuous data and as absolute frequencies with proportions for categorical data. The main outcome measure will be compared using a paired t-test. Correlations will be calculated using Pearsons correlation coefficient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment with an expected admittance of a minimum of 3 days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment with an expected admittance of a minimum of 3 days\n* Patients with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) are considered patients with treatment for OSA\n* Patients ≥ 18 years\n* Dutch or English speaking\n* Willing and able to sign consent for re-use of care data\n\nExclusion Criteria:\n\n* Patients \\< 18 years\n* Not speaking Dutch or English\n* Patients who do not sign consent for re-use of care data\n* Surgery scheduled in day case or with an expected discharge before the third night after surgery'}, 'identificationModule': {'nctId': 'NCT06586268', 'acronym': 'SNORE', 'briefTitle': 'The SNORE-trial: Analysis of Alterations in Sleep Stages Following Anesthesia and Their Relation to the Severity of Obstructive Sleep Apnea in the First 3 Nights After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The SNORE-trial: Postoperative REM-Sleep Disturbance iN Obstructive Sleep-apnea Patients and the Relation With AH-index', 'orgStudyIdInfo': {'id': '2024.0163'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients scheduled for elective surgery with a diagnosis of obstructive sleep apnea (OSA)', 'description': '* Patients scheduled for elective surgery at the operating theatres of the AUMC with a diagnosis of OSA with or without treatment\n* Patients with continuous positive airway pressure (CPAP) or mandibular advancement device (MAD) are considered patients with treatment for OSA\n* Patients ≥ 18 years\n* Dutch or English speaking\n* Willing and able to sign consent for re-use of care data'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Martin Rutten, Msc, MD', 'role': 'CONTACT', 'email': 'm.v.rutten@amsterdamumc.nl', 'phone': '+31(0)205669111', 'phoneExt': '28657'}, {'name': 'Martin Rutten, Msc, MD', 'role': 'CONTACT', 'email': 'm.v.rutten@amsterdamumc.nl', 'phone': '+31 (0)653326924'}, {'name': 'Martin Rutten, Msc, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AmsterdamUMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Martin Rutten', 'role': 'CONTACT', 'email': 'm.v.rutten@amsterdamumc.nl', 'phone': '+31 6 50075296'}, {'name': 'Luca den Tenter', 'role': 'CONTACT', 'email': 'l.m.dententer@amsterdamumc.nl', 'phone': '+31 205669111', 'phoneExt': '28657'}, {'name': 'Martin Rutten', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam UMC location VuMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Martin V.H. Rutten, Msc, MD', 'role': 'CONTACT', 'email': 'm.v.rutten@amsterdamumc.nl', 'phone': '+31205669111', 'phoneExt': '28657'}, {'name': 'Jeroen Hermanides, Prof. Dr.', 'role': 'CONTACT', 'email': 'j.hermanides@amsterdamumc.nl', 'phone': '+310205669111', 'phoneExt': '62533'}], 'overallOfficials': [{'name': 'Jeroen Hermanides, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AmsterdamUMC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Study protocol, ICF (standard model) with SAP are available upon request as of now. (september 2024) Data will be available until 5 year after publishing.', 'ipdSharing': 'YES', 'description': 'Study-protocol: will be available upon request SAP ,ICV, CSR will all be able on request. Data will be anonymized when data shared is patient specific.\n\nThere is no analytical code involved in our study. therefore this will not be shared.', 'accessCriteria': 'Only the researchteam will have direct acces to the researchdata and specific patient data.\n\nExternal requests will be evaluated by the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'VU University of Amsterdam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc, MD', 'investigatorFullName': 'Martin Rutten', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}