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

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.

Completed

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Key information

Conditions

Respiration Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

29 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Every patient undergoing an overnight polysomnography study can be included.

Exclusion criteria

None

Treatment and study plan

Non-Contact Respiratory Rate Monitor

Device

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.

Sponsors and collaborators

Lead sponsor

Kai Medical, Inc.

Industry

Registry information

Official study 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?

Important dates

Study start: 2010
Study completion: 2011
First posted: Aug 6, 2010
Registry last updated: Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed