Back to resultsArtificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
computer model
Polysomnogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea focused on measuring artificial neural network
Eligibility Criteria
Inclusion Criteria:
- Must be an adult (≥18 years old)
- Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.
Exclusion Criteria:
- Pregnancy or breast feeding
- Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction < 35%).
- Patients with end-stage renal disease on hemodialysis
- Patients with CVA, Parkinson, neuromuscular degenerative disease.
- Patient on narcotics.
- Patients with severe lung disease requiring oxygen at night and/or during the day.
- Patient with predominant insomnia or sleep hygiene problems, and who are not considered for PSG by the sleep specialist.
Sites / Locations
- Veterans Affairs Medical Center in Buffalo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
artificial neural network
Polysomnogram
Arm Description
Outcomes
Primary Outcome Measures
To demonstrate that using an ANN directed management of OSA is not inferior to PSG directed management of OSA in terms of sleepiness related functional outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT01286636
First Posted
January 27, 2011
Last Updated
January 12, 2016
Sponsor
State University of New York at Buffalo
Collaborators
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01286636
Brief Title
Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
Official Title
Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. The CDSS is based on deploying an artificial neural network (ANN) derived from anthropomorphic and clinical characteristics.
The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be diagnosed with the use of ANN without undergoing a sleep study, and that empiric management with auto-CPAP has similar outcomes to those who undergo a formal sleep study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
artificial neural network
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
artificial neural network
Arm Type
Experimental
Arm Title
Polysomnogram
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
computer model
Intervention Description
Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.
Intervention Type
Other
Intervention Name(s)
Polysomnogram
Intervention Description
Diagnosis of sleep apnea will rely on polysomnogram
Primary Outcome Measure Information:
Title
To demonstrate that using an ANN directed management of OSA is not inferior to PSG directed management of OSA in terms of sleepiness related functional outcome
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be an adult (≥18 years old)
Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.
Exclusion Criteria:
Pregnancy or breast feeding
Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction < 35%).
Patients with end-stage renal disease on hemodialysis
Patients with CVA, Parkinson, neuromuscular degenerative disease.
Patient on narcotics.
Patients with severe lung disease requiring oxygen at night and/or during the day.
Patient with predominant insomnia or sleep hygiene problems, and who are not considered for PSG by the sleep specialist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali El-Solh, MD, MPH
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Medical Center in Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
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