Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

NCT ID: NCT01286636

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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artificial neural network

Group Type EXPERIMENTAL

computer model

Intervention Type OTHER

Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.

Polysomnogram

Group Type ACTIVE_COMPARATOR

Polysomnogram

Intervention Type OTHER

Diagnosis of sleep apnea will rely on polysomnogram

Interventions

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computer model

Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.

Intervention Type OTHER

Polysomnogram

Diagnosis of sleep apnea will rely on polysomnogram

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Ali El Solh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali El-Solh, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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Veterans Affairs Medical Center in Buffalo

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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ANN02

Identifier Type: -

Identifier Source: org_study_id

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