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

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850434
• Other study ID #: MA20041125
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Est. completion date: November 2008

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Modified AutoSet Algorithm
The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm
• Standard AutoSet Algorithm
The standard AutoSet used for treatment of OSA

Locations

Country	Name	City	State
Australia	Sleep & Chest Disorders Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	sleep signals taken from overnight polysomnography recordings	Two consecutive nights