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

NCT ID: NCT01176539

Last Updated: 2011-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiration

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sleep Clinic

Non-Contact Respiratory Rate Monitor

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

29 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kai Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Kai Medical, Inc.

Locations

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Stanford Sleep Medicine Center

Redwood City, California, United States

Site Status

Countries

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United States

Other Identifiers

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18324

Identifier Type: OTHER

Identifier Source: secondary_id

KAI-00005

Identifier Type: -

Identifier Source: org_study_id

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