Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02723032
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2016-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of accuracy in patients', 'timeFrame': 'At baseline', 'description': 'Assessment of the accuracy of the novel pulse oximeter sensor in patients qualifying for LTOT over the entire saturation range by calculating accuracy root mean square (ARMS). Continuous SpO2 measurement of the novel pulse oximeter will be compared to measurements assessed by 2 standard pulse oximeters and arterial blood gas analysis.'}], 'secondaryOutcomes': [{'measure': 'Assessment of accuracy in healthy volunteers', 'timeFrame': 'At baseline', 'description': 'Assessment of accuracy of the novel pulse oximeter sensor in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation. SpO2 will be measured continuously over the hole procedure and SpO2 range by the novel pulse oximeter sensor and the 2 reference pulse oximeters.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pulse Oximeter Validation', 'Long Term Oxygen Therapy', 'Hypoxemia']}, 'descriptionModule': {'briefSummary': 'By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses using a closed-loop system.', 'detailedDescription': 'Objectives:\n\n1. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation.\n2. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters and to arterial blood gas analysis in patients qualifying for LTOT, breathing room air at rest (lying, sitting, standing position) and during exercise (slow walking, 6-MWT, ergometer cycle).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy volunteers\n\nInclusion Criteria:\n\n* Age 18 - 60 years,\n* Non smoker,\n* Good general health and physical fitness\n* Informed Consent\n\nExclusion Criteria:\n\n* Current or history of tobacco smoking (\\> 5 py)\n* Current alcohol or drug abuse\n* Heart disease or untreated arterial hypertension\n* Pulmonary disease\n* Epilepsy or other major neurologic disease\n* Dark skin colour\n* Known anemia\n* Severe metabolic disease (e.g. diabetes)\n* Pregnancy\n\nPatients\n\nInclusion Criteria:\n\n* Age ≥ 18 years\n* Long term oxygen therapy at rest and/or on physical effort\n* Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or \\< 60 mmHg with PHT or polycythemia (men Hb \\> 174 g/L, women Hb \\> 140 g/L) or:\n\nOxygen desaturation on effort (SpO2 \\< 90%)\n\n* Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease and Sarcoidosis\n* Informed Consent\n\nExclusion Criteria:\n\n* Severe hypoxemia (pO2 \\<40 mmHg)\n* Severe hypercapnia (pCO2 \\>55 mmHg)\n* Acute respiratory infection or systemic infection,\n* Severe systolic heart disease (LVEF \\< 25%)\n* Myocardial infarction during the last month before inclusion\n* Unstable angina pectoris\n* Severe aortic stenosis (mean gradient \\> 40mmHg, valve area \\<1 cm2)\n* Rhythmogenic heart disease\n* Severe or untreated arterial hypertension (blood pressure \\> 180mmHg systolic, \\>100mmHg diastolic)\n* Anemia (Hb \\< 120 g/l)\n* Known or suspected coagulation disorder (e.g. INR \\> 4)\n* Severe or untreated metabolic disorder\n* Neurologic disease or dementia\n* Pregnancy\n* History of non-compliance to medical treatment\n* Current alcohol, drug abuse or current tobacco smoking\n* Dark skin color'}, 'identificationModule': {'nctId': 'NCT02723032', 'acronym': 'OxyFrame', 'briefTitle': 'Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy.', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. A Prospective, Method Comparison, Proof of Concept Study.', 'orgStudyIdInfo': {'id': 'OxyFrame'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy Subjects and patients', 'description': 'Validation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step.', 'interventionNames': ['Device: OxyFrame']}], 'interventions': [{'name': 'OxyFrame', 'type': 'DEVICE', 'description': 'Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.', 'armGroupLabels': ['Healthy Subjects and patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Department of Pulmonary Medicine, University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Manuela Funke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pulmonary Medicine, University Hospital Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}