Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT07098793
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cough Monitoring in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute exacerbation of COPD alert system performance', 'timeFrame': '90-190 days', 'description': 'the ratio of successful alerts of acute exacerbations of COPD to false positive alerts.'}], 'secondaryOutcomes': [{'measure': 'number of successfull alerts of Acute exacerbations of COPD', 'timeFrame': '90-180 days', 'description': 'Total number of alerts of acute exacerbations of COPD identified by change in cough'}, {'measure': 'Number of False positive alerts of Acute Exacerbation of COPD', 'timeFrame': '90-180 days', 'description': "Total number of Acute exacerbation alerts detected by monitoring cough that didn't result in a acute exacerbation of COPD"}, {'measure': 'correlation cough counts with questionnaire data', 'timeFrame': '90-180 days', 'description': 'correlate Hull airway reflux questionnaire scores, cough visual analgue scale with average cough counts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cough', 'COPD', 'COPD Exacerbation']}, 'referencesModule': {'references': [{'pmid': '21115606', 'type': 'RESULT', 'citation': 'Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.'}, {'pmid': '23806051', 'type': 'RESULT', 'citation': 'de Oliveira JC, de Carvalho Aguiar I, de Oliveira Beloto AC, Santos IR, Filho FS, Sampaio LM, Donner CF, Oliveira LV. Clinical significance in COPD patients followed in a real practice. Multidiscip Respir Med. 2013 Jun 28;8(1):43. doi: 10.1186/2049-6958-8-43.'}, {'pmid': '19017866', 'type': 'RESULT', 'citation': 'Burgel PR, Nesme-Meyer P, Chanez P, Caillaud D, Carre P, Perez T, Roche N; Initiatives Bronchopneumopathie Chronique Obstructive (BPCO) Scientific Committee. Cough and sputum production are associated with frequent exacerbations and hospitalizations in COPD subjects. Chest. 2009 Apr;135(4):975-982. doi: 10.1378/chest.08-2062. Epub 2008 Nov 18.'}, {'pmid': '8630597', 'type': 'RESULT', 'citation': 'Vestbo J, Prescott E, Lange P. Association of chronic mucus hypersecretion with FEV1 decline and chronic obstructive pulmonary disease morbidity. Copenhagen City Heart Study Group. Am J Respir Crit Care Med. 1996 May;153(5):1530-5. doi: 10.1164/ajrccm.153.5.8630597.'}, {'pmid': '16120227', 'type': 'RESULT', 'citation': 'Ekberg-Aronsson M, Pehrsson K, Nilsson JA, Nilsson PM, Lofdahl CG. Mortality in GOLD stages of COPD and its dependence on symptoms of chronic bronchitis. Respir Res. 2005 Aug 25;6(1):98. doi: 10.1186/1465-9921-6-98.'}]}, 'descriptionModule': {'briefSummary': "This is an observational study designed to learn about symptoms of cough and how changes in cough may be associated with the beginning of a COPD exacerbation (acute worsening of symptoms.\n\nThe Investigators are looking to recruit patients diagnosed with COPD who have had two or more exacerbations of their disease within the last year requiring treatment with antibiotics or corticosteroids.\n\nThe main question aimed to be answered is whether the cough monitor can detect changes in a patient's clinical condition.\n\nPatients will be screened for participation in the study and a medical history will be taken alongside details of current medications, height, weight, vital signs as well and smoking status.\n\nThe patients will be asked to complete 3 questionnaires and the cough monitor will be installed in the room within their home where they sleep.\n\nPatients will be asked to complete a daily diary for 90 to a maximum of 180 days and leave the monitor recording cough throughout this time.", 'detailedDescription': "COPD is associated with disabling, progressive symptoms with episodes of rapid worsening termed acute exacerbations (AECOPD). It poses a significant global health challenge with AECOPD often resulting in the use of unscheduled care services including hospital attendance and admission. In addition to trying to prevent AECOPD, strategies have been developed to identify clinical deterioration early prompting intervention in the community with the aim of preventing unscheduled care service utilization.\n\nTelemonitoring refers to the use of technology to monitor patients' clinical condition in their own homes. One of the proposed benefits of telemonitoring is the early detection of clinical deterioration. At present, COPD telemonitoring relies on daily symptom reporting and monitoring of basic physiological data including heart rate and pulse oximetry. However, current strategies lack specificity resulting in difficulty identifying true exacerbations from normal day to day variation.\n\nCough and sputum production are reported by 60-80% of COPD patients, are increased at the time of exacerbation, and are associated with accelerated lung function decline, frequent exacerbations, and earlier mortality. It has previously been demonstrated that change in cough frequency at the time of exacerbation can be detected using a cough monitor that utilizes cough classifier software to analyse ambient sound. In the context of telemonitoring, this has the potential to facilitate the early detection of clinical change using an objective measure that does not require patient effort.\n\nRemote monitoring of COPD patients in their own homes aims to detect clinical deterioration early prompting intervention in the community with the aim of preventing utilization of unscheduled care services. Current systems do not succeed in reaching this target . A pilot study of remote cough monitoring has demonstrated that cough frequency was significantly increased during COPD exacerbation and trends in cough frequency can be detected using remote microphones and automated cough counting software. In a follow-up study, a cough-based alert system has been constructed showing promising performance. This prospective evaluation will validate the constructed system in a further COPD patient cohort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with current diagnosis of COPD who have had at least 2 moderate exacerbations of their COPD within the last year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Clinical diagnosis of COPD using GOLD criteria.\n\n * 2 or more moderate and/or severe exacerbations of COPD in the previous year\\*.\n * Clinical stability (i.e. absence of exacerbation requiring oral corticosteroids and/or antibiotics) for at least 4 weeks prior to enrollment.\n * Current or ex-smoker with ≥10 pack-year smoking history\n * Provision of informed consent\n\nExclusion Criteria:\n\n* • Children \\< age of 18\n\n * Failure to provide consent\n * Other significant comorbid medical or psychological condition that is deemed by the principal investigator to affect cough frequency or the subject's ability to comply with monitoring procedures."}, 'identificationModule': {'nctId': 'NCT07098793', 'briefTitle': 'Cough Monitoring in COPD', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'Cough Monitoring in COPD:a Mixed Methods Observational Study', 'orgStudyIdInfo': {'id': 'COPD2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patient with COPD', 'description': 'Patients with frequent exacerbations of COPD', 'interventionNames': ['Device: Cough monitoring']}], 'interventions': [{'name': 'Cough monitoring', 'type': 'DEVICE', 'description': 'continuous recording of cough in patients sleeping area for 90-180 days', 'armGroupLabels': ['patient with COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'East Yorkshiure', 'country': 'United Kingdom', 'facility': 'Redspiratory mMedicine, First Floor, Daisy Building, Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Philips Electronics Nederland B.V. acting through Philips CTO organization', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}