Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:46 AM
Study NCT ID:
NCT07422350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2025-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Speaking Valve on Physiological Parameters With Wearable Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2025-09-07', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of differences in key physiological parameters between two patient groups', 'timeFrame': 'Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).', 'description': 'Primary endpoint: Whether the tracheostomy patient\'s first use of a speaking valve is successful,duration of use 30 minutes.Primary Objectives:Data from 120 patients were collected using wearable devices,including respiratory rate(RR),heart rate(HR),fingertip blood oxygen saturation(SaO₂),respiratory movement amplitude(RMA),etc.RR and HR refer to the average respiratory and heart rates per minute during monitoring,respectively(breaths/min,beats/min).SaO₂ represents the average oxygen saturation recorded during monitoring(%).RMA means the average thoracic respiratory movement amplitude during monitoring(mm).This study aims to identify factors that can predict successful tolerance of the speaking valve, enhance the decannulation process focused on the "speaking valve," and increase the the success rate of decannulation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['difficult decannulation', 'tracheostomized patients', 'Wearable devices', 'speaking valves'], 'conditions': ['Tracheostomy Decannulation']}, 'descriptionModule': {'briefSummary': 'To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.', 'detailedDescription': 'A speaking valve (such as the common one-way valve/Passy-Muir type) is a one-way device attached to the external opening of a tracheostomy tube: the valve opens during inhalation, allowing air to flow in through the tracheostomy tube; it closes during exhalation, directing airflow upwards through the glottis and out through the mouth and nose, thereby restoring upper airway exhalation, vibrating the vocal cords to produce sound, and enhancing functions such as swallowing, smell, taste, and secretion clearance. This study aims to gather physiological parameter data using non-invasive wearable devices during speaking valve use, compare the differences between before and after wearing speaking valve.It also compares key physiological parameters between the group that can tolerate the speaking valve and the group that cannot. Identify objective indicators associated with successful tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population:Tracheostomy patients in a rehabilitation hospital undergoing pre-decannulation rehabilitation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is not receiving mechanical ventilation.\n2. Tolerates cuff deflation.\n3. Upper airway patency is good, TTP \\< 10 cmH2O.\n4. Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.\n5. PaCO2\\<60 mmHg.\n\nExclusion Criteria:\n\n1. Cannot tolerate deflation balloon.\n2. Severe upper airway obstruction\n3. Unstable vital signs.\n4. Thick secretions, compromised airway protection.\n5. PaCO2 ≥60 mmHg.'}, 'identificationModule': {'nctId': 'NCT07422350', 'acronym': 'Effect of SV', 'briefTitle': 'The Effect of Speaking Valve on Physiological Parameters With Wearable Devices', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'The Effect of Speaking Valve on Physiological Parameters of Tracheostomized Patients With Wearable Devices', 'orgStudyIdInfo': {'id': '2025-bjkfyy-twdmp-svt'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tolerance Cohort', 'description': 'Tolerance group: Successfully wears a speaking valve for the predefined time threshold (first wearing time = 30 minutes), with a Borg dyspnea score ≤ 3, and no significant CO₂ retention (PaCO₂ \\< 60 mmHg).'}, {'label': 'Intolerance Cohort', 'description': 'Intolerance group: occurrence of any of the following during the 30-minute wearing period-marked increase in subjective dyspnea score; need for premature speaking valves removal; sustained SaO2 decrease ≥3%; severe or persistent cough; decompensated respiratory acidosis or PaCO2 ≥ 60 mmHg.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100043', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hong ying Jiang', 'role': 'CONTACT', 'email': '6jhy@163.com', 'phone': '+8601056981555'}], 'facility': 'Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Bin Zhang', 'role': 'CONTACT', 'email': 'zbzgzjz@sina.com', 'phone': '+8618600530758'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jingyi Ge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Rehabilitation Hospital', 'class': 'OTHER'}, {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jingyi Ge', 'investigatorAffiliation': 'Capital Medical University'}}}}