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CPAP Titration Using an Artificial Neural Network: A Randomized Controlled Study

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artificial Neural Network
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring sleep apnea, titration, CPAP, neural network

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients 18 years of age and older,
  2. documented OSA by sleep study defined as AHI > 5/hr

Exclusion Criteria:

  1. previously treated OSA,
  2. unwilling to undergo a titration study,
  3. unable or unwilling to sign an informed consent.

Sites / Locations

  • State University of New York at Buffalo

Outcomes

Primary Outcome Measures

Time to achieve optimal CPAP

Secondary Outcome Measures

Failure Rate of CPAP titration

Full Information

First Posted
July 5, 2007
Last Updated
November 23, 2020
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT00497640
Brief Title
CPAP Titration Using an Artificial Neural Network: A Randomized Controlled Study
Official Title
CPAP Titration Using an Artificial Neural Network: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Study was terminated due to lack of interest from subjects and no funding, only 1 subject signed consent but did not participate.
Study Start Date
May 2007 (Actual)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine the validity of the prediction model in reducing the rate of CPAP titration failure and in achieving a shorter time to optimal pressure
Detailed Description
In order to derive the most effective pressure, CPAP titration is performed in the sleep laboratory during which the pressure is gradually increased until apneas and hypopneas are abolished in all sleep stages and in all body positions. The technique is however time consuming and labor intensive. Furthermore, the duration of the study may not be sufficient to attain this goal because of patient's poor ability to sleep in this environment or due to difficulty in attaining an appropriate pressure. A predictive algorithm based on demographic, anthropometric, and polysomnographic data was developed to facilitate the selection of a starting pressure during the overnight titration study. Yet, the performance of this model was inconsistent when validated by other centers. One of the potential reasons for the lack of reproducibility is the complex relation of behavioral processes with nonlinear attributes. In areas of complex interactions, the artificial neural network (ANN) has been found to be a more appropriate alternative to linear, parametric statistical tools due to its inherent property of seeking information embedded in relations among variables thought to be independent. Comparison: time to achieve optimal pressure in the conventional technique versus the intervention model

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, titration, CPAP, neural network

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Artificial Neural Network
Intervention Description
Use of a predicted optimal CPAP
Primary Outcome Measure Information:
Title
Time to achieve optimal CPAP
Time Frame
minutes
Secondary Outcome Measure Information:
Title
Failure Rate of CPAP titration
Time Frame
percentage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients 18 years of age and older, documented OSA by sleep study defined as AHI > 5/hr Exclusion Criteria: previously treated OSA, unwilling to undergo a titration study, unable or unwilling to sign an informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali A El Solh, MD, MPH
Organizational Affiliation
Sate University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17512788
Citation
El Solh AA, Aldik Z, Alnabhan M, Grant B. Predicting effective continuous positive airway pressure in sleep apnea using an artificial neural network. Sleep Med. 2007 Aug;8(5):471-7. doi: 10.1016/j.sleep.2006.09.005. Epub 2007 May 18.
Results Reference
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CPAP Titration Using an Artificial Neural Network: A Randomized Controlled Study

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