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

NCT ID: NCT00850434

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-11-30

Brief Summary

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

Detailed Description

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

modified autoset

the modified AutoSet responds to different breathing patterns than the standard AutoSet, to treat OSA. Participants in this arm will trial the modified AutoSet for one night, and the standard AutoSet for one night, in a randomised order

Group Type: EXPERIMENTAL

Modified AutoSet Algorithm

Intervention Type: DEVICE

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

Standard AutoSet Algorithm

Intervention Type: DEVICE

The standard AutoSet used for treatment of OSA

standard AutoSet

The standard autoset treat OSA by using pressure increases to overcome abnormal breathing patterns. Patients in this arm will use the standard AutoSet for one night and the modified AutoSet for one night, in a randomised order

Group Type: ACTIVE_COMPARATOR

Modified AutoSet Algorithm

Intervention Type: DEVICE

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

Standard AutoSet Algorithm

Intervention Type: DEVICE

The standard AutoSet used for treatment of OSA

Interventions

Modified AutoSet Algorithm

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

Intervention Type: DEVICE

Standard AutoSet Algorithm

The standard AutoSet used for treatment of OSA

Intervention Type: DEVICE

Other Intervention Names

Enhanced AutoSet algorithm

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Klaus Schindhelm, PhD

Role: PRINCIPAL_INVESTIGATOR

ResMed / University of NSW

Locations

Sleep & Chest Disorders Centre

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

MA20041125

Identifier Type: -

Identifier Source: org_study_id