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Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01286636
Recruitment Status : Withdrawn
First Posted : January 31, 2011
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Ali El Solh, State University of New York at Buffalo

Tracking Information
First Submitted Date  ICMJE January 27, 2011
First Posted Date  ICMJE January 31, 2011
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
Official Title  ICMJE Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sleep Apnea
Intervention  ICMJE
  • Other: computer model
    Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.
  • Other: Polysomnogram
    Diagnosis of sleep apnea will rely on polysomnogram
Study Arms  ICMJE
  • Experimental: artificial neural network
    Intervention: Other: computer model
  • Active Comparator: Polysomnogram
    Intervention: Other: Polysomnogram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2011)
56
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01286636
Other Study ID Numbers  ICMJE ANN02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ali El Solh, State University of New York at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE VA Office of Research and Development
Investigators  ICMJE
Principal Investigator: Ali El-Solh, MD, MPH State University of New York at Buffalo
PRS Account State University of New York at Buffalo
Verification Date January 2016

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