Skip to main content
OpenTrials
Completed

NCT Number: NCT00850434

Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)

The purpose of this study is to compare a modified AutoSet algorithm running on research hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study will determine if the modified AutoSet algorithm reacts appropriately to obstructive apnoeas and hypopnoeas and provides suitable levels of positive airway pressure compared to the S7 AutoSet Spirit.

The hypothesis is that the modified AutoSet algorithm will be more efficacious than the traditional AutoSet algorithm

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep & Chest Disorders Centre

Sydney, New South Wales, 2000, Australia

About this study

Subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full montage polysomnograph (PSG) with each of the algorithms providing positive airway pressure therapy. The PSG records EEG, EMG, EOG, patient airflow, respiratory effort, blood oxygen saturation, and body position.

In a randomised order each subject will spend one night being treated by the modified AutoSet algorithm and a second night being treated by the traditional AutoSet algorithm.

The subjects will be blinded to which therapy they are receiving and the scorer of the PSG will also be blinded to which therapy is being used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PSG-confirmed diagnosis of OSA, showing an apnoea-hypopnoea index (AHI) of at least 15 events/hr and an obstructive apnoea index (OAI) of at least 5 events/hr.
  • On CPAP therapy (fixed pressure or autoCPAP) for at least 1 month.
  • Using a ResMed mask (this requirement applies only to phase 2 of the trial) without significant discomfort for at least 2 weeks.
  • Age between 18 and 70 years.
  • Written informed consent.

Exclusion criteria

  • Unstable medical condition, including unstable angina, myocardial infarction within previous 6 months, cardiac failure NYHA grades III and IV, epilepsy, psychiatric disturbance.
  • Respiratory insufficiency, defined as arterial CO2 greater than 50 mm Hg during the daytime or arterial oxygen saturation less than 90% when asleep and breathing room air on effective CPAP therapy.
  • Recent severe epistaxis.
  • History of spontaneous pneumothorax.
  • History of regurgitation of gastric contents during sleep.
  • Unable to give written informed consent.

Treatment and study plan

Modified AutoSet algorithm

Device

The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm

Other names: Enhanced AutoSet algorithm

Standard AutoSet algorithm

Device

The standard AutoSet used for treatment of OSA

Primary outcomes

  1. Physiological sleep signals including EEG, Sp02, respiratory effort and nasal flow, will be recorded, analysed and reported in the form of a series of indices, which are the outcome variables of the study.

    Time frame: Two consecutive nights

    sleep signals taken from overnight polysomnography recordings

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 25, 2009
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.