Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-28 @ 3:05 AM
Study NCT ID:
NCT05325658
Status:
COMPLETED
Last Update Posted:
2024-07-16
First Post:
2021-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005249', 'term': 'Fees and Charges'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-14', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the influence of modified diet, exercise and electrical swallowing muscle stimulation on swallowing function and quality of life in elderly patients with oropharyngeal dysphagia.', 'timeFrame': '2021-2024', 'description': 'Primary outcomes focus on domains within reduction in the severity of oropharyngeal dysphagia and a reduction in the risk of aspiration after administration of a modified diet, electrical swallowing muscle stimulation and exercise to improve swallowing, after 10 days. The Penetration - Aspiration (J.C. Rosenbek et al., 1996) scale will be used before and after treatment to evaluate FEES. Assessing FEES: The higher the score, the more severe the disease.'}, {'measure': 'Evaluation of the influence of modified diet, exercise and electrical swallowing muscle', 'timeFrame': '2021-2024', 'description': 'Dysphagia Handicap Index (DHI): The higher the score, the more severe oropharyngeal dysphagia.'}, {'measure': 'Evaluation of the influence of modified diet, exercise and electrical swallowing muscle', 'timeFrame': '2021-2024', 'description': 'SWAL-QoL / SWAL-CARE: frequency scale (in questions 3, 5, 6, 9) and an evaluation scale (in questions 1, 2, 4, 7, 8), in the form of a 5-point Likert scale, where 1 corresponds to worst QoL and 5 to best QoL.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oropharyngeal Dysphagia']}, 'descriptionModule': {'briefSummary': 'Tasks of biomedical research:\n\n1. To determine the severity of oropharyngeal dysphagia and the risk of aspiration in elderly patients.\n2. To evaluate the quality of life of older patients with oropharyngeal dysphagia by performing validation of the Lithuanian version of the quality of life questionnaires in patients with oropharyngeal dysphagia.\n3. To evaluate the severity of oropharyngeal dysphagia in elderly patients, the risk of aspiration, and quality of life after interventions.\n\nData on the sex, age and disease of the swallowing disorder will be collected. No processing of other personal data and health indicators is planned. All data will be collected in questionnaires. The data will be depersonalized by giving the patient a code.\n\nThe results and conclusions of the research will be described in the doctoral dissertation and will be used for scientific articles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Geriatric patients treated at Kaunas Hospital who meet the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 60 years of age and older;\n* Swallowing disorder suspected during hospitalization - oropharyngeal dysphagia;\n* Patient's written consent.\n\nExclusion Criteria:\n\n* severe oropharyngeal dysphagia (when feeding into the stomach through a nasogastric tube is required);\n* Significant respiratory or heart failure: dyspnoea (respiratory rate\\> 20 rpm, SpO2 \\<90%), tachycardia (HR\\> 100 rpm);\n* very severe malnutrition (severe exhaustion, severe signs of sarcopenia);\n* final stage of oncological disease;\n* severe dementia (Short Mental Test (MMSE) \\<10 points);\n* Ingestion assessment with a fibroendoscope (FEES) did not reveal any swallowing problems (no dysphagia)."}, 'identificationModule': {'nctId': 'NCT05325658', 'briefTitle': 'Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Lithuanian University of Health Sciences'}, 'officialTitle': 'Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia', 'orgStudyIdInfo': {'id': '2.3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oropharyngeal dysphagia', 'description': 'Patients with oropharyngeal dysphagia. Patients will be examined before and after combination therapy.', 'interventionNames': ['Other: FEES, treatment with modified diet, electrical swallowing muscle stimulation.']}], 'interventions': [{'name': 'FEES, treatment with modified diet, electrical swallowing muscle stimulation.', 'type': 'OTHER', 'description': 'Endoscopic swallowing assessment (FEES) consists of three parts:1) assessment of mouth, throat anatomy and more; 2) the patient is given to swallow a certain amount and consistency of liquids and solid food. 3) evaluated: preparation of the bolus for swallowing, aspiration. An 8-point Penetration-Aspiration scale is described.Swallowing exercises. Swallowing exercises are also used in practice, which can help coordinate the swallowing muscles or stimulate the nerves involved in the swallowing reflex.Transcutaneous electrical stimulation is a method of treating dysphagia in which weak electrical impulses stimulate the muscles in the neck area associated with swallowing. In patients with oropharyngeal dysphagia, patients have great difficulty swallowing water of normal consistency or other non-thick liquids, so they should be thickened with special thickeners to such an extent that the patient does not experience discomfort and be able to swallow.', 'armGroupLabels': ['Oropharyngeal dysphagia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Margarita Rugaitienė', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lithuanian University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Margarita Rugaitiene', 'investigatorAffiliation': 'Lithuanian University of Health Sciences'}}}}