New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults (APAP)

April 3, 2012 updated by: Compumedics Limited

New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults: Randomised Non-inferiority Double Blinded Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Department of Respiratory & Sleep Medicine, Monash Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Autoset S8
Single night auto-titrating CPAP treatment using the reference device (Resmed Autoset S8) with polysomnographic monitoring
Device: Resmed Autoset S8 - Auto-titrating CPAP

Subjects will undergo the auto-titrating CPAP treatments in the Monash Sleep Centre with the test and reference devices during two nights in random order. There will be an interval of at least seven days between the two treatments to eliminate the carry-over effect.

Full polysomnographic (PSG) recording will be conducted during both treatment nights. The recorded physiological signals during PSG will include signals identical to those used during the baseline diagnostic PSG. The patients fill KSS questionnaire immediately after the PSG study.

All PSG recordings (both treatment studies and the baseline diagnostic study) will be scored according to the AASM rules by the same sleep technician blinded to the presence and type of auto-titrating CPAP treatment.

Other Names:
  • Autoset S8
Experimental: Somnilink SPAP
Single night auto-titrating CPAP treatment using the test device with polysomnographic monitoring
Device: Compumedics Somnilink SPAP - Auto-titrating CPAP

Subjects will undergo the auto-titrating CPAP treatments in the Monash Sleep Centre with the test and reference devices during two nights in random order. There will be an interval of at least seven days between the two treatments to eliminate the carryover effect.

Full polysomnographic (PSG) recording will be conducted during both treatment nights. The recorded physiological signals during PSG will include signals identical to those used during the baseline diagnostic PSG. The patients fill KSS questionnaire immediately after the PSG study.

All PSG recordings (both treatment studies and the baseline diagnostic study) will be scored according to the AASM rules by the same sleep technician blinded to the presence and type of auto-titrating CPAP treatment.

Other Names:
  • Somnilink SPAP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment
Time Frame: Up to 8 weeks after study completion
AHI is the number of apnea and hypopnea events per hour of sleep
Up to 8 weeks after study completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AHI difference between test treatment and baseline
Time Frame: Up to 8 weeks after study completion

AHI is the number of apnea and hypopnea events per hour of sleep.

This endpoint is introduced to further demonstrate effectiveness of the test treatment in addition to the body of knowledge deduced from historical evidence for the reference treatment and selection conditions of the margin of non-inferiority
Up to 8 weeks after study completion
Arousal Index (AI) differences between the test and reference APAP treatments and between the test treatment and baseline
Time Frame: Up to 8 weeks after study completion

AI is the number of occurrences of arousal events per hour of sleep.

AI differences will be tested between test and control as non-inferiority, and between test and baseline as superiority.
Up to 8 weeks after study completion
Respiratory Disturbance Index (RDI) differences between the test and reference APAP treatments and between the test treatment and baseline
Time Frame: Up to 8 weeks after study completion

RDI is the number of respiratory events (apneas and hypopneas) and respiratory event related arousals (RERA) [39] per hour of sleep.

RDI will be tested between test and control as non-inferiority, and between test and baseline as superiority.
Up to 8 weeks after study completion
Sleep Efficiency (SE) differences between the test and reference APAP treatments and between the test treatment and baseline
Time Frame: Up to 8 weeks after study completion

SE is defined as the ratio of sleep time to the time in bed.

SE will be tested between test and control as non-inferiority, and between test and baseline as superiority.
Up to 8 weeks after study completion
Oxygen desaturation index (DI) differences between the test and reference APAP treatments and between the test treatment and baseline
Time Frame: Up to 8 weeks after study completion

DI is defined as the number of oxygen desaturations >= 3% per hour of sleep.

DI will be tested between test and control as non-inferiority, and between test and baseline as superiority.
Up to 8 weeks after study completion
Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments.
Time Frame: The patients fill KSS questionnaire immediately after each PSG study
KSS is a simple questionnaire for subjective momentary evaluation of sleepiness/alertness [41]. A recent clinical trial [34] included subjective evaluation after polysomnography (PSG) as one of the secondary outcome measures. The KSS difference between the test treatment and baseline will not be estimated because KSS is included into the standard diagnostic PSG.
The patients fill KSS questionnaire immediately after each PSG study
Test treatment AHI
Time Frame: Up to 8 weeks after study completion
The study will test the hypothesis of the test treatment AHI being below a threshold of 9 that is within the range 5-10.
Up to 8 weeks after study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Compumedics Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Garun Hamilton, PhD, Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPAP001
  • 10244A (Other Identifier: Southern Health, Monash Medical Centre, Research Project No.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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