Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:09 AM
Study NCT ID:
NCT07402603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep-disordered Breathing Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2036-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients consenting to participation in a database', 'timeFrame': '5 years', 'description': 'From the whole cohort referred for a sleep study, the number of participants (percentage of the whole cohort) who sign a consent form and have data recorded will be calculated'}], 'secondaryOutcomes': [{'measure': 'Changes in symptoms and disease related variables', 'timeFrame': '5 years initially, further ethical approval will be sought at 5 years to extend the database further', 'description': 'Changes in symptom based scores - Epworth sleepiness score between baseline and follow up Changes in disease parametrics including: AHI (apnoea/hypopnoea index), blood gas measurements (PO2, PCO2, pH, HCO3), lung function between baseline and follow up Additional variables may be added over the duration of the database'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['database', 'observational'], 'conditions': ['Obstructive Sleep Apnoea (OSA)', 'Hypoventilation Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to collect clinical data on patients who have had a sleep study and are given a diagnosis of a sleep related breathing disorder such as obstructive sleep apnoea. Collecting this data in an organised way will mean that the investigators can monitor patients and their health outcomes.', 'detailedDescription': 'This is a prospective database collecting: symptom, physiological, comorbidity and treatment response data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population will be those patients under the sleep and ventilation service who have undertaken a sleep study and started on treatment for their sleep disordered breathing', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Referred to Royal Free London NHS Foundation Trust Sleep and Ventilation Service\n* Agreed to undertake a sleep study\n\nExclusion Criteria:\n\n* Inability to consent'}, 'identificationModule': {'nctId': 'NCT07402603', 'briefTitle': 'Sleep-disordered Breathing Database', 'organization': {'class': 'OTHER', 'fullName': 'Royal Free Hospital NHS Foundation Trust'}, 'officialTitle': 'Enhancing Patient Care: Sleep and Ventilation Database', 'orgStudyIdInfo': {'id': '25-WS-0157'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleep disordered breathing', 'description': 'Patients who are referred for a sleep study to investigate sleep disordered breathing'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Swapna Mandal, PhD', 'role': 'CONTACT', 'email': 'swapnamandal@nhs.net', 'phone': '+442077940500', 'phoneExt': '23359'}], 'facility': 'Royal Free London NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Swapna Mandal, PhD', 'role': 'CONTACT', 'email': 'swapnamandal@nhs.net', 'phone': '+442077940500', 'phoneExt': '23359'}, {'name': 'Amar Shah, PhD', 'role': 'CONTACT', 'email': 'amar.shah5@nhs.net', 'phone': '+442077940500', 'phoneExt': '23359'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Other researchers may apply for access to the database, provided they demonstrate a valid scientific and public benefit and meet all governance requirements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Free Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}