Monitor Patients With Sleep Apnea (ARMADA)
This study has been completed.
Sponsor:
Corventis, Inc.
Information provided by:
Corventis, Inc.
ClinicalTrials.gov Identifier:
NCT00918502
First received: June 10, 2009
Last updated: February 2, 2010
Last verified: February 2010
| Tracking Information | |||||
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| First Received Date ICMJE | June 10, 2009 | ||||
| Last Updated Date | February 2, 2010 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00918502 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monitor Patients With Sleep Apnea | ||||
| Official Title ICMJE | Adherent Respiratory Monitoring for Apnea Detection and Evaluation Study | ||||
| Brief Summary | 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 |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | sleep study |
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| Condition ICMJE | Sleep Apnea | ||||
| Intervention ICMJE | Device: AVIVO system
Non invasive external monitoring device |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00918502 | ||||
| Other Study ID Numbers ICMJE | COR-2009-004 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Madhuri Bhat, VP Regulatory and Clinical affairs, Corventis | ||||
| Study Sponsor ICMJE | Corventis, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Corventis, Inc. | ||||
| Verification Date | February 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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