Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-11 @ 1:35 AM
Study NCT ID:
NCT04031950
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2019-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2019-07-23', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity and sensitivity of novel device', 'timeFrame': '6 months', 'description': 'specificity and sensitivity of the output of the novel wearable device against polysomnography'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.\n\nThe Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.', 'detailedDescription': "The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.\n\nThe Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.\n\nPatients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device.\n\nAt the end of the trial, we will compare the diagnosis results from both systems."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all children who have been referred for a sleep test.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children older than one year old\n* Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.\n\nExclusion Criteria:\n\n* Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.\n* Known allergy to the adhesive dressing.\n* Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.\n* Patients with not enough space on the neck area to fit the sensor.\n* Clinical problem in the area in which the device will be attached, eg skin condition'}, 'identificationModule': {'nctId': 'NCT04031950', 'briefTitle': 'Clinical Evaluation of a Paediatric Sleep Diagnosis Technology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acurable Ltd.'}, 'officialTitle': 'Clinical Evaluation of a Paediatric Sleep Diagnosis Technology', 'orgStudyIdInfo': {'id': '269747'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'test group', 'description': 'Test group will wear PSG', 'interventionNames': ['Device: Novel wearable paediatric device']}, {'label': 'Novel wearable device', 'description': 'THis group will wear the novel device', 'interventionNames': ['Device: Novel wearable paediatric device']}], 'interventions': [{'name': 'Novel wearable paediatric device', 'type': 'DEVICE', 'description': 'The patient will wear the novel wearable paediatric device at the same time as polysmnography', 'armGroupLabels': ['Novel wearable device', 'test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S10 2TH', 'city': 'Sheffield', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Orsina Dessi', 'role': 'CONTACT', 'email': 'orsina@acurable.com', 'phone': '+447721 877020'}, {'name': 'Heather Elphick', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheffield Children Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Orsina Dessi', 'role': 'CONTACT'}, {'name': 'Hazel Evans', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Southampton Children's Hospital", 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'centralContacts': [{'name': 'Orsina Dessi, MEng', 'role': 'CONTACT', 'email': 'orsina@acurable.com', 'phone': '+447721 877020'}], 'overallOfficials': [{'name': 'Ruth Kingshott, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Sheffield Children's NHS Foundation Trust"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acurable Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Sheffield Children's NHS Foundation Trust", 'class': 'OTHER'}, {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}