N/A
N=24
Performance Validation of a Non-contact Breathing Frequency Monitor (Model BM07)
Unspecified Threat to Breathing
Bottom Line
View on ClinicalTrials.gov: NCT01319396 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices — 0.28 breaths per minute
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiration Rate Accuracy - Mean Difference in Breaths Per Minute Between the BM07 5GHz Sensor and SomnoScreen Devices |
0.28 | — |
Summary
The purpose of this study is to compare the accuracy of the BiancaMed BM07 breathing frequency indicator device with the respiration rate measured by a SomnoScreen RC Easy device on 20+ human volunteers. This is being carried out in support of a 510(k) submission.
Eligibility Criteria
Inclusion Criteria
- volunteer
- consent
Exclusion Criteria: none
Data sourced from ClinicalTrials.gov (NCT01319396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.