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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01176539
First Posted: August 6, 2010
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kai Medical, Inc.
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176539


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

Responsible Party: Bob Nakata, Chief Technology Officer, Kai Medical, Inc.
ClinicalTrials.gov Identifier: NCT01176539     History of Changes
Other Study ID Numbers: KAI-00005
18324 ( Other Identifier: Stanford University )
First Submitted: August 4, 2010
First Posted: August 6, 2010
Last Update Posted: June 8, 2011
Last Verified: June 2011