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Monitor Patients With Sleep Apnea (ARMADA)

This study has been completed.
Sponsor:
Information provided by:
Corventis, Inc.
ClinicalTrials.gov Identifier:
NCT00918502
First received: June 10, 2009
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  Purpose

The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography


Condition Intervention
Sleep Apnea
 Device: AVIVO system

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Corventis, Inc.:

Estimated Enrollment: 30
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AVIVO system
    Non invasive external monitoring device
Detailed Description:

Patients with suspected sleep disordered breathing will be monitored during polysomnography and the collected information will be used to assess patient's respiratory status.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

sleep study

Criteria

Inclusion Criteria:

  • Is female or male, 18 years of age or older
  • Undergoing polysomnography for suspected sleep apnea
  • Is willing to provide written informed consent and comply with study guidelines
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918502

Sponsors and Collaborators
Corventis, Inc.
Investigators
Study Director: Imad Libbus, PhD Corventis, Inc.
  More Information

No publications provided

Responsible Party: Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis
ClinicalTrials.gov Identifier: NCT00918502     History of Changes
Other Study ID Numbers: COR-2009-004
Study First Received: June 10, 2009
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013