Tissue oxygen saturation measurement during arterial desaturation study

Not Applicable

Completed

• Conditions: Sleep apnea (SA), chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH) and heart failure (HF); Not Applicable

• Registration Number: ISRCTN30656608
• Lead Sponsor: Medtronic Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-09
• Study Completion: 2020-02-17
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified