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

June 10, 2009
February 2, 2010
March 2009
July 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00918502 on ClinicalTrials.gov Archive Site
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Monitor Patients With Sleep Apnea
Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study

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

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

sleep study

Sleep Apnea
Device: AVIVO system
Non invasive external monitoring device
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00918502
COR-2009-004
No
Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis
Corventis, Inc.
Not Provided
Study Director: Imad Libbus, PhD Corventis, Inc.
Corventis, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP