---
title: Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
nct_id: NCT01286636
overall_status: WITHDRAWN
phase: PHASE3
sponsor: State University of New York at Buffalo
study_type: INTERVENTIONAL
primary_condition: Sleep Apnea
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01286636.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01286636"
ct_last_update_post_date: 2016-01-13
last_seen_at: "2026-05-12T07:20:54.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

**NCT ID:** [NCT01286636](https://clinicaltrials.gov/study/NCT01286636)

## Key Facts

- **Status:** WITHDRAWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** State University of New York at Buffalo
- **Collaborators:** VA Office of Research and Development
- **Conditions:** Sleep Apnea
- **Start Date:** 2011-01
- **Completion Date:** 2015-06
- **CT.gov Last Update:** 2016-01-13

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **artificial neural network** (EXPERIMENTAL)
- **Polysomnogram** (ACTIVE_COMPARATOR)

## Interventions

- **computer model** (OTHER) — Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.
- **Polysomnogram** (OTHER) — Diagnosis of sleep apnea will rely on polysomnogram

## Primary Outcomes

- **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** _(time frame: 6 weeks)_

## Locations (1)

- Veterans Affairs Medical Center in Buffalo, Buffalo, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.veterans affairs medical center in buffalo|buffalo|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01286636.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01286636*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*