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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00497640
Other study ID # MED4890507E
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2007
Est. completion date June 2009

Study information

Verified date September 2009
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2009
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Procedure:
Artificial Neural Network
Use of a predicted optimal CPAP

Locations

Country Name City State
United States State University of New York at Buffalo Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 May 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to achieve optimal CPAP minutes
Secondary Failure Rate of CPAP titration percentage
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