Clinical trial NCT01210261: New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults
Official title: New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults: Randomised Non-inferiority Double Blinded Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: OSA
CPAP
APAP
SPAP
Obstructive Sleep Apnea
Sleep Apnea
Lead sponsor: Compumedics Limited
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by intermittent partial and/or complete upper airway obstruction during sleep. The participants, naive to nasal continuous positive airway pressure (CPAP), recently diagnosed with OSA, will undergo two automatic CPAP titration studies with collection of polysomnographic (PSG) data. The data will be analysed to assess effectiveness of Compumedics auto-CPAP device in the normalisation of sleep disordered breathing in OSA patients, with respect to another auto-CPAP device.

Detailed description: Auto-titrating CPAP (APAP) using algorithms based on detection of flow limitation and snoring have been developed. Auto-titration devices adjust nasal pressure to the minimum pressure needed to maintain airway patency at any point in time and can accommodate a range of background states that affect airway collapsibility and hence CPAP pressure requirement including sedation, alcohol, airway inflammation, body position and sleep state.

Compumedics Limited has developed an APAP device (Somnilink SPAP based on the new algorithm technology of characterising breaths and determination of inspiratory flow limitation. The objectives of this new technology are to enable accurate detection of inspiratory intervals for irregular breathing patterns that are likely to occur during REM sleep, sleep onset and wakefulness as well as to provide correct characterisation of inspiratory flow limitation. These features could translate in delivery of superior treatment because of improved sensitivity and specificity of respiratory event detection and earlier pressure response to inspiratory flow limitation. Demonstration of superiority of the Somnilink SPAP device relative to existing APAP treatment devices will be subject of future clinical trials (beyond the scope of this protocol). An early clinical trial of a pre-production version of Somnilink SPAP with the pressure control algorithm identical to the production version established non-inferiority for AHI relative to a reference APAP (Resmed Autoset Spirit) with the differential AHI estimate of -0.91 \[-2.80; 0.91\] (Mean \[95%CI\]). The Somnilink SPAP device is now available as a production version (CE and TGA approved) and the purpose of the current study is to establish its non-inferiority compared to an existing APAP device (Resmed Autoset S8).

The treatment will be administered on the two nights of polysomnographic studies (PSG) by means of continuous air pressure delivery under the variable pressure levels determined by the APAP device to maintain the upper airway patency.

The population of adult patients newly diagnosed with OSA after undergoing a diagnostic PSG study in the sleep laboratory with no previous CPAP treatment experience and complying with the eligibility criteria (as outlined below) will be studied.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18.
* Ability to give informed consent.
* OSA diagnosis and referral for clinical CPAP implementation at the Monash Sleep Centre within 3 months of recruitment.

Exclusion Criteria:

* Inability to give informed consent.
* Significant central sleep apnea (AHI for central events \>= 5).
* Congestive heart failure.
* Co-existing obesity related hypoventilation.
* Nasal obstruction, mouth breathing or other anatomical or physiological conditions making CPAP therapy inappropriate.
* History of prior CPAP treatment.
* Previous reaction to skin preparation, tapes and electrode gels used at PSG.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment
timeFrame: Up to 8 weeks after study completion
Secondary outcomes:
measure: AHI difference between test treatment and baseline
timeFrame: Up to 8 weeks after study completion
measure: Arousal Index (AI) differences between the test and reference APAP treatments and between the test treatment and baseline
timeFrame: Up to 8 weeks after study completion
measure: Respiratory Disturbance Index (RDI) differences between the test and reference APAP treatments and between the test treatment and baseline
timeFrame: Up to 8 weeks after study completion
measure: Sleep Efficiency (SE) differences between the test and reference APAP treatments and between the test treatment and baseline
timeFrame: Up to 8 weeks after study completion
measure: Oxygen desaturation index (DI) differences between the test and reference APAP treatments and between the test treatment and baseline
timeFrame: Up to 8 weeks after study completion
measure: Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments.
timeFrame: The patients fill KSS questionnaire immediately after each PSG study
measure: Test treatment AHI
timeFrame: Up to 8 weeks after study completion
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Department of Respiratory & Sleep Medicine, Monash Medical Centre
state: Victoria
Study officials:
affiliation: Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre
name: Garun Hamilton, PhD
role: PRINCIPAL_INVESTIGATOR
References: