Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor
How Does the New Kai R Spot 100 Respiratory Monitor Compare to the Currently Used Respiratory Monitor for Measuring Respiratory Rate During Overnight Sleep Studies?
2 other identifiers
observational
50
1 country
1
Brief Summary
The purpose of this study is to determine whether the respiratory rate provided by Kai Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the currently used methods, including respiratory chest bands.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 4, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 8, 2011
June 1, 2011
August 4, 2010
June 6, 2011
Conditions
Study Arms (1)
Sleep Clinic
Interventions
The Non-Contact Respiratory Rate Monitor provides a measurement of respiratory rate at a single point in time for neonates, pediatrics and adults. The Non-Contact Respiratory Rate Monitor provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults.
Eligibility Criteria
Subjects at the Sleep Center at Stanford Universoty
You may qualify if:
- Every patient undergoing an overnight polysomnography study can be included.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Sleep Medicine Center
Redwood City, California, 94063, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 4, 2010
First Posted
August 6, 2010
Study Start
March 1, 2010
Study Completion
March 1, 2011
Last Updated
June 8, 2011
Record last verified: 2011-06