{ "data": { "asOf": "2026-10-30T22:24:48.433Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07568119", "title": "Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care", "scientificTitle": "Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care", "status": "active", "studyType": "observational", "phase": [], "conditions": [ "Cystic Fibrosis (CF)", "Non Cystic Fibrosis Bronchiectasis", "Chronic Obstructive Pulmonary Disease (COPD)" ], "interventions": [ { "name": "Airway clearance therapy through acoustic oscillations", "type": "DEVICE", "description": "The investigational intervention is the SonoHeal device, an adaptive airway clearance therapy (ACT) system designed to enhance mucus mobilization through individualized pressure/acoustic oscillations. The device utilizes the Forced Oscillation Technique (FOT) to continuously measure respiratory impedance, including airway resistance and reactance, during therapy.\n\nDuring each treatment session, patients use the SonoHeal device for a defined duration consistent with standard ACT practices. The device delivers high-frequency pressure oscillations intended to loosen and mobilize mucus within the airways, facilitating expectoration. Outcome measures associated with the intervention include changes in lung function parameters (e.g., resistance and reactance), sputum production during therapy, and overall treatment response." } ], "sponsor": { "name": "Cognita Labs LLC", "type": "INDUSTRY" }, "locations": [ { "city": "Santa Ana", "country": "United States", "facility": "Ventura County Medical Center" } ], "outcomes": { "other": [], "primary": [ "Qualitative assessment", "Time taken for training session", "Time taken for therapy duration" ], "secondary": [ "System Usability Questionnaire Assessment", "Wet weight of sputum", "Spirometry", "Airway impedance" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Diagnosis of CF established by either genetic screening or positive chloride sweat test (Sweat chloride concentrations \\> 60mmol/L).\n* Diagnosis of NCFB or COPD requiring regular use of airway clearance therapy.\n* Age older than 11 years.\n* History of chronic daily sputum production.\n* Currently on a home therapeutic regimen that includes some form of ACT performed at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.\n* Stage I eligibility for the 3 subjects will require patients who have had ≥2 ACT session with the VEST® in-clinic with lung function measured pre-post therapy.\n* FVC and FEV1 \\> 35%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 2 months).\n* Evaluated at the Ventura County Medical Center 2 or more times in the preceding 12 months.\n* Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject.\n* Ability to understand study requirements and comply with study procedures. Individuals of all ethnicities are included.\n\nExclusion Criteria:\n\n* Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.\n* Hemoptysis \\> 60 cc in a single episode in the 4 weeks preceding enrollment.\n* Chronic chest pain.\n* Participation in another clinical trial in the previous 30 days.\n* Use of intravenous antibiotics in the 2 months preceding enrollment.\n* Inability or unwillingness of the participant to give written informed consent.", "minimumAge": "11 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 15 }, "startDate": "2024-02-17", "completionDate": "2028-06-30", "lastUpdated": "2026-10-22T00:00:00.000Z", "firstPosted": "2026-05-05T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07568119" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07568119", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07568119", "sourceUrl": "https://clinicaltrials.gov/study/NCT07568119", "sourceStatus": "ACTIVE_NOT_RECRUITING", "retrievedAt": "2026-10-28T04:32:26.122Z", "payloadSha256": "13842621a7adc723fc45b42996e443b31facd62c62fd5152f21d30d7e107055e", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07568119", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07568119", "verifyAt": "https://clinicaltrials.gov/study/NCT07568119", "retrievedAt": "2026-10-28T04:32:26.122Z", "payloadSha256": "13842621a7adc723fc45b42996e443b31facd62c62fd5152f21d30d7e107055e", "text": "ClinicalTrials.gov, record NCT07568119 (https://clinicaltrials.gov/study/NCT07568119), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07568119, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.", "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there." }, "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served." }, "_meta": { "api": "The Last Economy Wire: World Trials API", "version": "1.0", "schemaVersion": "1", "correlationId": "req_9MlzkkI5Lln3", "generatedAt": "2026-10-30T22:24:48.433Z", "documentation": "https://negativeresistance.com/embed", "license": "Free for any use. Attribution appreciated.", "degraded": false, "provenance": { "sources": [ "clinicaltrials_gov" ], "attribution": { "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs" }, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "limitations": [], "provenanceEndpoint": "/api/v1/sources" }, "freshness": { "newestEvidenceAt": null, "lastSyncedAt": { "clinicaltrials_gov": "2026-10-28T04:33:30.663Z" }, "degradedSources": [], "worldwide": false, "maxAgeHours": 65.9, "fromCache": false }, "links": { "discovery": "https://negativeresistance.com/api/v1", "openapi": "https://negativeresistance.com/api/v1/openapi.json", "mcp": "https://negativeresistance.com/api/v1/mcp", "agentCard": "https://negativeresistance.com/.well-known/agent.json", "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json", "sdk": "https://negativeresistance.com/api/v1/sdk", "status": "https://negativeresistance.com/api/v1/status", "provenance": "https://negativeresistance.com/api/v1/sources", "contract": "https://negativeresistance.com/api/v1/contract", "curriculum": "https://negativeresistance.com/api/v1/curriculum", "graph": "https://negativeresistance.com/api/v1/graph", "openQuestions": "https://negativeresistance.com/api/v1/open-questions", "scoreboard": "https://negativeresistance.com/api/v1/scoreboard", "findings": "https://negativeresistance.com/api/v1/findings", "claims": "https://negativeresistance.com/api/v1/claims", "threads": "https://negativeresistance.com/api/v1/threads", "assignment": "https://negativeresistance.com/api/v1/assignment", "changes": "https://negativeresistance.com/api/v1/changes", "hello": "https://negativeresistance.com/api/v1/hello", "errors": "https://negativeresistance.com/api/v1/errors", "webhooks": "https://negativeresistance.com/api/v1/webhooks", "a2a": "https://negativeresistance.com/api/v1/a2a", "deadEnds": "https://negativeresistance.com/api/v1/dead-ends", "decompositions": "https://negativeresistance.com/api/v1/decompositions", "rungs": "https://negativeresistance.com/api/v1/rungs", "methods": "https://negativeresistance.com/api/v1/methods", "reality": "https://negativeresistance.com/api/v1/reality", "council": "https://negativeresistance.com/api/v1/council", "calibration": "https://negativeresistance.com/api/v1/calibration", "freshness": "https://negativeresistance.com/api/v1/freshness", "mission": "https://negativeresistance.com/api/v1/mission", "twin": "https://negativeresistance.com/api/v1/twin", "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment", "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell", "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model", "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json", "collaborate": "https://negativeresistance.com/collaborate", "manifesto": "https://negativeresistance.com/about", "documentation": "https://negativeresistance.com/embed", "connect": "https://negativeresistance.com/connect", "llmsTxt": "https://negativeresistance.com/llms.txt", "llmsFullTxt": "https://negativeresistance.com/llms-full.txt" }, "disclaimer": "Research data from public registries and literature; not medical advice." } }