Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT06525857
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observing Physiological Changes in Patients With Long-term Oxygen Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate changes from before and during LTOT', 'timeFrame': 'From 1 week before start of LTOT to 1 month after start of LTOT', 'description': 'Record heart rate (BPM) to compare before and during LTOT'}, {'measure': 'Respiratory rate changes from before and during LTOT', 'timeFrame': 'From 1 week before start of LTOT to 1 month after start of LTOT', 'description': 'Record respiratory rate (breaths per minute) to compare before and during LTOT'}, {'measure': 'SpO2 changes from before and during LTOT', 'timeFrame': 'From 1 week before start of LTOT to 1 month after start of LTOT', 'description': 'Record SpO2 (%) to compare before and during LTOT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'In this project, the investigators aim to assess changes of physiological parameters obtained non-invasively through PPG and accelerometry signals between before and during LTOT (long-term oxygen therapy) and investigate if those changes are different in patients with worsening frailty and/or improving quality of life.\n\nFor this, they will record optical (PPG) and accelerometry data via a datalogger on 40 patients undergoing LTOT and assess the PPG-derived physiological signals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a respiratory disease and newly prescribed LTOT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18-year-old, and\n* Chronic respiratory disease including a) chronic obstructive pulmonary disease, b) interstitial lung disease, c) pulmonary hypertension, d) bronchiectasis, and\n* Prescribed new LTOT due to a chronic respiratory disease with resting and/or exertional hypoxemia, and\n* Able to speak/read/understand German or French, and\n* Willing and able to understand and provide signed informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or\n* Inability to follow the procedures/instructions of the study (e.g. due to language, psychological disorders, dementia, etc.), or\n* Patients having a subordination link to the investigators, or\n* Patients with isolated nocturnal oxygen therapy or LTOT prescription for a heart disease, sleep associated breathing disorder, neuromuscular disease or lung cancer, or\n* Known participation in another human research project (ClinO/HRO) that may affect the objectives of this study.'}, 'identificationModule': {'nctId': 'NCT06525857', 'briefTitle': 'Observing Physiological Changes in Patients With Long-term Oxygen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Observing Physiological Changes in Patients With Long-term Oxygen Therapy Via Optical and Accelerometry Signals', 'orgStudyIdInfo': {'id': 'STD0006706'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LTOT', 'type': 'OTHER', 'description': 'Patients with newly prescribed LTOT will be monitored for physiological changes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Sabina Guler', 'role': 'CONTACT', 'email': 'sabina.guler@insel.ch'}], 'facility': 'Inselspital, Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Sabina Guler, PD Dr. med.', 'role': 'CONTACT', 'email': 'sabina.guler@insel.ch', 'phone': '+41 31 66 4 48 92'}], 'overallOfficials': [{'name': 'Sabina Guler, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinik für Pneumologie, Allergologie und klinische Immunologie, Inselspital Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}