Incorporating Flow Limitation Into the Diagnosis and Quantification of Sleep Disordered Breathing
Primary Purpose
Sleep-Disordered Breathing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-invasive technique to diagnose and quantitate sleep-disordered breathing
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep-Disordered Breathing
Eligibility Criteria
Inclusion Criteria: Patients with sleep disordered breathing
Sites / Locations
- NYU Sleep Disorders Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004569
First Posted
February 12, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00004569
Brief Title
Incorporating Flow Limitation Into the Diagnosis and Quantification of Sleep Disordered Breathing
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
Brief Summary
The diagnosis and treatment of sleep disordered breathing have come to the forefront of clinical medicine following recognition of the high prevalence and associated morbidity of sleep apnea. The effects on quality of life as well as societal costs have been well documented. The NYU Sleep Research Laboratory has spent the last several years working on the problem of improving the diagnosis of mild sleep disordered breathing which manifests as the upper airway resistance syndrome. Our approach has been to develop a non-invasive technique to detect increased upper airway resistance directly from analysis of the airflow signal. A characteristic intermittent change of the inspiratory flow contour, which is indicative of the occurrence of flow limitation, correlates well with increased airway resistance.
Currently all respiratory events are identified manually and totaled. This is time consuming and subject to variability. The objective of the present project is to improve upon the manual approach by implementing an artificially intelligent system for the identification and quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary signals collected during a routine sleep study. The utility of other reported indices of sleep disordered breathing obtained during a sleep study will be evaluated.
Successful development of an automated system that can identify and classify upper airway resistance events will simplify, standardize and improve the diagnosis of sleep disordered breathing, and greatly facilitate research and clinical work in this area. Using a physiological based determination of disease should allow better assessment of treatment responses in mild disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-Disordered Breathing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Non-invasive technique to diagnose and quantitate sleep-disordered breathing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with sleep disordered breathing
Facility Information:
Facility Name
NYU Sleep Disorders Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Incorporating Flow Limitation Into the Diagnosis and Quantification of Sleep Disordered Breathing
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