NCT00497640

Brief 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 25, 2020

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

July 5, 2007

Last Update Submit

November 23, 2020

Conditions

Obstructive Sleep Apnea

Keywords

sleep apnea, titration, CPAP, neural network

Outcome Measures

Primary Outcomes (1)

  • Time to achieve optimal CPAP

    minutes

Secondary Outcomes (1)

  • Failure Rate of CPAP titration

    percentage

Interventions

Artificial Neural NetworkPROCEDURE

Use of a predicted optimal CPAP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients 18 years of age and older,
  • documented OSA by sleep study defined as AHI \> 5/hr

You may not qualify if:

  • previously treated OSA,
  • unwilling to undergo a titration study,
  • unable or unwilling to sign an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14215, United States

Location

Related 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. doi: 10.1016/j.sleep.2006.09.005. Epub 2007 May 18.

    PMID: 17512788BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesMicrocephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ali A El Solh, MD, MPH

    Sate University of New York at Buffalo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

May 1, 2007

Primary Completion

July 1, 2008

Study Completion

June 1, 2009

Last Updated

November 25, 2020

Record last verified: 2009-09

Locations

US(1)