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NCT01176539 Clinical Trial

Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor

Respiration Clinical Trial

Official title:
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?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01176539
Other study ID # KAI-00005
Secondary ID 18324
Status Completed
Phase N/A
First received August 4, 2010
Last updated June 6, 2011
Start date March 2010
Est. completion date March 2011

Study information
Verified date June 2011
Source Kai Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2011
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Every patient undergoing an overnight polysomnography study can be included.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Device:
• Non-Contact Respiratory Rate Monitor
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.

Locations
Country Name City State
United States Stanford Sleep Medicine Center Redwood City California

Sponsors (1)
Lead Sponsor Collaborator
Kai Medical, Inc.

Country where clinical trial is conducted

United States, 

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