Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 5:22 AM
Study NCT ID:
NCT05106569
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telespirometry in Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-09', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)', 'timeFrame': '2 week intervals for 6 months', 'description': 'Minimum 0, Maximum 48; Lower scores worse'}, {'measure': 'Change from baseline SVC percent predicted at clinic', 'timeFrame': '3 months', 'description': 'SVC measured at clinic in seated and supine positions using conventional and portable spirometer'}, {'measure': 'Change from baseline SVC percent predicted at clinic', 'timeFrame': '6 months', 'description': 'SVC measured at clinic in seated and supine positions using conventional and portable spirometer'}, {'measure': 'Change from baseline SVC percent predicted at home', 'timeFrame': '2 week intervals for 6 months', 'description': 'SVC measured from home in seated and supine positions using portable spirometer'}, {'measure': 'Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)', 'timeFrame': '2 week intervals for 6 months', 'description': 'Minimum 0, Maximum 30; Higher scores worse'}, {'measure': 'Change from baseline Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '6 months', 'description': 'Minimum 0, Maximum 42; Higher scores worse'}, {'measure': 'Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months', 'timeFrame': '6 months', 'description': 'Minimum 0, Maximum 20; Higher scores worse'}, {'measure': 'Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)', 'timeFrame': '6 months', 'description': 'Minimum 0, Maximum 20; Lower scores worse'}, {'measure': 'Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS) ALS Caregiver Behavioral Questionnaire at 6 months', 'timeFrame': '6 months', 'description': 'Minimum 0, Maximum 45; Lower scores worse'}, {'measure': 'Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire', 'timeFrame': '2 week intervals for 6 months', 'description': 'Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Pulmonary Function Test', 'Amyotrophic Lateral Sclerosis', 'Slow Vital Capacity'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '30957547', 'type': 'BACKGROUND', 'citation': 'Geronimo A, Simmons Z. Evaluation of remote pulmonary function testing in motor neuron disease. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Aug;20(5-6):348-355. doi: 10.1080/21678421.2019.1587633. Epub 2019 Apr 7.'}, {'pmid': '27598295', 'type': 'BACKGROUND', 'citation': 'Hegewald MJ, Gallo HM, Wilson EL. Accuracy and Quality of Spirometry in Primary Care Offices. Ann Am Thorac Soc. 2016 Dec;13(12):2119-2124. doi: 10.1513/AnnalsATS.201605-418OC.'}, {'pmid': '16319028', 'type': 'BACKGROUND', 'citation': 'Couratier P, Vincent F, Torny F, Lacoste M, Melloni B, Lemaire F, Antonini MT. Spirometer-dependence of vital capacity in ALS: validation of a portable device in 52 patients. Amyotroph Lateral Scler Other Motor Neuron Disord. 2005 Dec;6(4):239-45. doi: 10.1080/14660820510043244.'}, {'pmid': '20650985', 'type': 'BACKGROUND', 'citation': 'Masa JF, Gonzalez MT, Pereira R, Mota M, Riesco JA, Corral J, Zamorano J, Rubio M, Teran J, Farre R. Validity of spirometry performed online. Eur Respir J. 2011 Apr;37(4):911-8. doi: 10.1183/09031936.00011510. Epub 2010 Jul 22.'}, {'pmid': '31613151', 'type': 'BACKGROUND', 'citation': 'Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.'}, {'pmid': '30486680', 'type': 'RESULT', 'citation': 'Rutkove SB, Qi K, Shelton K, Liss J, Berisha V, Shefner JM. ALS longitudinal studies with frequent data collection at home: study design and baseline data. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Feb;20(1-2):61-67. doi: 10.1080/21678421.2018.1541095. Epub 2018 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.', 'detailedDescription': 'SVC is obtained with in-clinic conventional spirometry, in-clinic portable spirometry, and in-home portable spirometry with respiratory therapist-supervised remote pulmonary function testing every two weeks in a six month prospective study of participants with a diagnosis of Amyotrophic Lateral Sclerosis. SVC decline over time, seated and supine, will be tracked with assessments for treatment changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are invited to volunteer and recruited from ALS specialty care outpatient clinics at SUNY Upstate and Atrium Health.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS\n2. 18 years old to 100 years old, English-speaking ALS subjects, male and female\n\nExclusion Criteria:\n\n1. Use of non-invasive ventilation more than 16 hours daily\n2. Non-English Speaker\n3. Psychosis or severe mental illness\n4. Use of high-dose sedating psychotropic medications determined to potentially interfere with task performance\n5. Infection Control issues and specific Pulmonary, Cardiac, Vascular contraindications as listed in the Standardization of Spirometry 2019 Update (Graham 2019)'}, 'identificationModule': {'nctId': 'NCT05106569', 'briefTitle': 'Telespirometry in Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis (ALS)', 'orgStudyIdInfo': {'id': '1660190'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SUNY Upstate', 'description': 'One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.', 'interventionNames': ['Diagnostic Test: Spirometry']}, {'label': 'Atrium Health', 'description': 'One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.', 'interventionNames': ['Diagnostic Test: Spirometry']}], 'interventions': [{'name': 'Spirometry', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Pulmonary Function Test'], 'description': 'All study participants will undergo pulmonary function testing using conventional spirometry in clinic and portable spirometry in clinic and at home. In-clinic conventional laboratory spirometry is compared with portable spirometry and Slow vital capacity is obtained in upright and supine positions.', 'armGroupLabels': ['Atrium Health', 'SUNY Upstate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Eufrosina Young, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY Upstate'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '2 years.', 'ipdSharing': 'YES', 'description': 'The plan is to share Individual Patient Data collected during the study to research team from both sites.', 'accessCriteria': 'Research team includes Principal investigators, sub-investigators, clinical research coordinators and respiratory therapists at each site, Pulmonologist Central Readers at SUNY Upstate. Deidentified data is shared with study sponsor MTPA.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanabe Pharma America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eufrosina I. Young', 'investigatorAffiliation': 'State University of New York - Upstate Medical University'}}}}