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

This study has been completed.
Sponsor:
Information provided by:
Kai Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01176539
First received: August 4, 2010
Last updated: June 6, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Respiration
 Device: Non-Contact Respiratory Rate Monitor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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?

Further study details as provided by Kai Medical, Inc.:

Enrollment: 50
Study Start Date: March 2010
Study Completion Date: March 2011
Groups/Cohorts Assigned Interventions
Sleep Clinic 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects at the Sleep Center at Stanford Universoty

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176539

Locations
United States, California
Stanford Sleep Medicine Center
Redwood City, California, United States, 94063
Sponsors and Collaborators
Kai Medical, Inc.
  More Information

No publications provided

Responsible Party: Bob Nakata, Chief Technology Officer, Kai Medical, Inc.
ClinicalTrials.gov Identifier: NCT01176539     History of Changes
Other Study ID Numbers: KAI-00005, 18324
Study First Received: August 4, 2010
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013