Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT05432102
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2022-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Experience and Technical Success of Community Sleep Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-20', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-06-20', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfactory sleep studies', 'timeFrame': '3 months', 'description': "The proportion of home studies to diagnose sleep apnoea that are satisfactory without disruption to the patient's sleep or loss of signals to an extent that make the results unreliable."}], 'secondaryOutcomes': [{'measure': 'Extent of sleep disruption', 'timeFrame': '3 months', 'description': 'What proportion of patients report sleep disruption due to: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?'}, {'measure': 'Extent of signal failure', 'timeFrame': '3 months', 'description': 'What proportion of studies failed due to loss of signal from: oximeter probe / nasal cannula / thermistor / chest band /abdominal band / the recording device?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This study looks at the quality of the common mechanisms used to diagnose obstructive sleep apnoea (OSA) by patients in their own homes. These are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. This study will examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between.', 'detailedDescription': 'There is a study underway to develop a non-contact detector of breathing (SafeScan) as a new method of diagnosing obstructive sleep apnoea (OSA). There are a number of different methods already available to achieve this end but one proposed advantage of the new SafeScan device is that it will not affect sleep quality and because there are no measuring devices attached to the patient it is less likely that the signal will be lost in the night due to the normal movements of sleep. However there are no data available that quantify these factors as an issue for the current techniques and devices.\n\nThe proving study for SafeScan is a comparison of the ability of the device to measure sleep apnoea compared to full in-hospital polysomnography (PSG) and one outcome will be the proportion of studies that have lost data. However the future use of the SafeScan device will be in the community. The common diagnostics used by patients in their own homes are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. We propose a study to examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between. In addition there will be an analysis of the results to explore whether there are features of the patients such as age and obesity that make technical success or failure of the studies more likely.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing a home sleep study at Royal Papworth Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient able to provide assent by completion of the Research Questionnaire Adult patients (≥ 18 years of age) Patients undergoing a home sleep study\n\nExclusion Criteria:\n\nPatients unable to complete questionnaires due to language or other barriers'}, 'identificationModule': {'nctId': 'NCT05432102', 'acronym': 'PETSOCSS', 'briefTitle': 'Patient Experience and Technical Success of Community Sleep Studies', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papworth Hospital NHS Foundation Trust'}, 'officialTitle': 'Patient Experience and Technical Success of Community Sleep Studies', 'orgStudyIdInfo': {'id': 'P02530'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants having respiratory polygraphy', 'description': 'This label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period.', 'interventionNames': ['Diagnostic Test: Respiratory polygraphy']}, {'label': 'Participants having pulse oximetry', 'description': 'This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period.', 'interventionNames': ['Diagnostic Test: Pulse oxymetry']}], 'interventions': [{'name': 'Pulse oxymetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic intervention to diagnose OSA.', 'armGroupLabels': ['Participants having pulse oximetry']}, {'name': 'Respiratory polygraphy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic intervention to diagnose OSA.', 'armGroupLabels': ['Participants having respiratory polygraphy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Earl Palas', 'role': 'CONTACT', 'email': 'earl.palas@nhs.net', 'phone': '+44 1223 638410'}], 'facility': 'Royal Papworth Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Katharine Woodall', 'role': 'CONTACT', 'email': 'katharine.woodall@nhs.net', 'phone': '+44 1223 639636'}, {'name': 'Joanna Raynor', 'role': 'CONTACT', 'email': 'joanna.raynor1@nhs.net', 'phone': '+44 1223 639699'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papworth Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Iceni Laboratories', 'class': 'UNKNOWN'}, {'name': 'CRN Eastern', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}