Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

NCT01286636 | Withdrawn Phase 3

• 1 other identifier: ANN02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

artificial neural network

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Study Arms (2)

artificial neural network

EXPERIMENTAL

Other: computer model

Polysomnogram

ACTIVE COMPARATOR

Other: Polysomnogram

Interventions

computer model OTHER

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

artificial neural network

Polysomnogram OTHER

Diagnosis of sleep apnea will rely on polysomnogram

Polysomnogram

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be an adult (≥18 years old)
• Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• VA Office of Research and Development: collaborator

Study Sites (1)

Veterans Affairs Medical Center in Buffalo

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ali El-Solh, MD, MPH

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (1)