Clinical trial NCT00850434: Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Official title: Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Two consecutive nights
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sleep & Chest Disorders Centre
state: New South Wales
Study officials:
affiliation: ResMed / University of NSW
name: Klaus Schindhelm, PhD
role: PRINCIPAL_INVESTIGATOR
References: