Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-03 @ 5:56 AM
Study NCT ID:
NCT03710993
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2018-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy Assessment of Beddr Oximeter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-10-16', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2 accuracy', 'timeFrame': '60 minutes', 'description': 'Collect and analyze data to assess SpO2 calibration and accuracy'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oximetry']}, 'descriptionModule': {'briefSummary': 'Accuracy performance of Beddr oximeter', 'detailedDescription': 'This study will evaluate the accuracy of the Beddr sleepTuner oximeter compared to a transfer standard and multiple reference devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult volunteers, ranging in pigmentation from light to dark.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have the ability to understand and provide written informed consent\n* Adult subjects 18 up to 50 years of age\n* Subject must be willing and able to comply with study procedures and duration\n* Subject is a non-smoker or who has not smoked within 2 days prior to the study.\n* Male or female of any race\n* Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.\n\nExclusion Criteria:\n\n* Subject is considered as being morbidly obese (defined as BMI \\>39.5)\n* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)\n* Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study\n* Subjects with known respiratory conditions such as:\n\n * uncontrolled / severe asthma,\n * flu,\n * pneumonia / bronchitis,\n * shortness of breath / respiratory distress,\n * unresolved respiratory or lung surgery with continued indications of health issues,\n * emphysema, COPD, lung disease\n* Subjects with known heart or cardiovascular conditions such as:\n\n * Hypertension: systolic \\>140mmHg, Diastolic \\>90mmHg on 3 consecutive readings.\n * have had cardiovascular surgery\n * Chest pain (angina)\n * heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia\n * previous heart attack\n * blocked artery\n * unexplained shortness of breath\n * congestive heart failure (CHF)\n * history of stroke\n * transient ischemic attack\n * carotid artery disease\n * myocardial ischemia\n * myocardial infarction\n * cardiomyopathy\n* Self-reported health conditions as identified in the Health Assessment Form\n\n * diabetes,\n * uncontrolled thyroid disease,\n * kidney disease / chronic renal impairment,\n * history of seizures (except childhood febrile seizures),\n * epilepsy,\n * history of unexplained syncope,\n * recent history of frequent migraine headaches,\n * recent head injury within the last 2 months,\n * cancer / chemotherapy\n* Subjects with known clotting disorders\n\n * history of bleeding disorders or personal history of prolonged bleeding from injury\n * history of blood clots\n * hemophilia\n * current use of blood thinner: prescription or daily use of aspirin\n* Subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors\n* Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits.\n* Other known health condition, should be considered upon disclosure in health assessment form'}, 'identificationModule': {'nctId': 'NCT03710993', 'briefTitle': 'Accuracy Assessment of Beddr Oximeter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hancock Medical, Inc.'}, 'officialTitle': 'Beddr Sleep SpO2 Equivalency Calibration Study', 'orgStudyIdInfo': {'id': 'PR 2018-290'}}, 'armsInterventionsModule': {'interventions': [{'name': 'oximeter', 'type': 'DEVICE', 'description': 'Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding transfer standard and reference devices to assess oximeter calibration and accuracy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80027', 'city': 'Louisville', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinimark', 'geoPoint': {'lat': 39.97776, 'lon': -105.13193}}], 'overallOfficials': [{'name': 'Arthur Cabrera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinimark, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hancock Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}