Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01286636

Enrollment

Registered

2011-01-31

Start date

2011-01-31

Completion date

2015-06-30

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

artificial neural network

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.

Interventions

OTHERcomputer model

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

OTHERPolysomnogram

Diagnosis of sleep apnea will rely on polysomnogram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026