Sleep apnea (SA), chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH) and heart failure (HF) Not Applicable
Conditions
Interventions
The researchers are targeting four patient populations: SA, COPD, PAH and HF. The COPD/PAH/HF cohort will consist of subjects aged = 18 years who are scheduled to undergo a standard of care (SOC) six-
Sponsors
Medtronic Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be = 18 years old 2. Subject (or subject’s legally authorized representative) is willing and able to provide written informed consent 3. Sleep Apnea cohort: subjects undergoing a scheduled SOC sleep study who are expected to experience a minimum of 5% arterial oxygen desaturation 4. COPD/PAH/HF cohort: subjects undergoing a scheduled SOC 6MWT who are expected to experience a minimum of 5% arterial oxygen desaturation
Exclusion criteria
Exclusion criteria: 1. Subject has other medical conditions that would limit study participation (per physician discretion) 2. Subject has known allergies to medical adhesives and cannot tolerate placement of NoninTM SenSmartTM EQUANOXTM Advance sensor on chest 3. Subject has a disorder causing poor blood circulation to the fingers or a connective tissue disorder that would interfere with an accurate measurement of SpO2 in the fingers (per physician discretion) 4. Subject is unable or unwilling to participate in study procedures 5. Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment is any concurrent clinical study (including registries) requires approval of the study manager or designee 6. Subject with exclusion criteria required by local law
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tissue oxygen saturation (StO2) in the pectoral region during tissue oxygen desaturation, measured using external StO2 sensors at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Standard peripheral capillary oxygen saturation (SpO2), measured using an external SpO2 sensor at a single timepoint | — |
Countries
United States of America
Contacts
Public ContactJoy;Troy Aso;Penz
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Outcome results
None listed