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
  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
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, see Learn About Clinical Studies.

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 August 28, 2014