Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT01286636|
Recruitment Status : Withdrawn
First Posted : January 31, 2011
Last Update Posted : January 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Other: computer model Other: Polysomnogram||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||June 2015|
|Experimental: artificial neural network||
Other: computer model
Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.
|Active Comparator: Polysomnogram||
Diagnosis of sleep apnea will rely on polysomnogram
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286636
|United States, New York|
|Veterans Affairs Medical Center in Buffalo|
|Buffalo, New York, United States, 14215|
|Principal Investigator:||Ali El-Solh, MD, MPH||State University of New York at Buffalo|