Sleep Apnea, ObstructiveAPAPNCT01210261
New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults
A study testing Compumedics Somnilink SPAP - Auto-titrating CPAP and Resmed Autoset S8 - Auto-titrating CPAP in people with Sleep Apnea, Obstructive, run by Compumedics Limited at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Compumedics Somnilink SPAP - Auto-titrating CPAP and Resmed Autoset S8 - Auto-titrating CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- May 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Respiratory & Sleep Medicine, Monash Medical Centre
Clayton, Victoria, 3168
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Compumedics Somnilink SPAP - Auto-titrating CPAP, Resmed Autoset S8 - Auto-titrating CPAP
- Keywords
- OSA, CPAP, APAP, SPAP, Obstructive Sleep Apnea, Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compumedics Somnilink SPAP - Auto-titrating CPAPDevice
Also called Somnilink SPAP
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.
Resmed Autoset S8 - Auto-titrating CPAPDevice
Also called Autoset S8
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.
| Study group | Role | What they receive |
|---|---|---|
| Autoset S8 | Active comparator | Single night auto-titrating CPAP treatment using the reference device (Resmed Autoset S8) with polysomnographic monitoring Receives: Device: Resmed Autoset S8 - Auto-titrating CPAP |
| Somnilink SPAP | Experimental | Single night auto-titrating CPAP treatment using the test device with polysomnographic monitoring Receives: Device: Compumedics Somnilink SPAP - Auto-titrating CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment
AHI is the number of apnea and hypopnea events per hour of sleep
Measured: Up to 8 weeks after study completion
Secondary outcomes (7)
AHI difference between test treatment and baseline
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Up to 8 weeks after study completion
Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments.
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.
Measured: The patients fill KSS questionnaire immediately after each PSG study
Test treatment AHI
The study will test the hypothesis of the test treatment AHI being below a threshold of 9 that is within the range 5-10.
Measured: Up to 8 weeks after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compumedics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Garun Hamilton, PhD, Principal investigator, Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210261
- Sponsor's protocol ID
- SPAP001
- Other IDs
- 10244A
- Acronym
- APAP
- Status last verified
- Apr 2012
- First submitted
- 23 Sep 2010
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults: Randomised Non-inferiority Double Blinded Trial.
- ClinicalTrials.gov ID
- NCT01210261
- Acronym / sponsor ID
- APAP / SPAP001
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- OSA, CPAP, APAP, SPAP, Obstructive Sleep Apnea, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Compumedics LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autoset S8 | Active comparator | Device: Resmed Autoset S8 - Auto-titrating CPAPSingle night auto-titrating CPAP treatment using the reference device (Resmed Autoset S8) with polysomnographic monitoring |
| Somnilink SPAP | Experimental | Device: Compumedics Somnilink SPAP - Auto-titrating CPAPSingle night auto-titrating CPAP treatment using the test device with polysomnographic monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compumedics Somnilink SPAP - Auto-titrating CPAPAlso: Somnilink SPAPSubjects 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. | Device | Somnilink SPAP |
| Resmed Autoset S8 - Auto-titrating CPAPAlso: Autoset S8Subjects 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. | Device | Autoset S8 |
Primary outcome
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
7 secondary outcomes
AHI difference between test treatment and baseline
Time frame: 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
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
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
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
Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments.
Time frame: The patients fill KSS questionnaire immediately after each PSG study
Test treatment AHI
Time frame: Up to 8 weeks after study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garun Hamilton, PhD principal investigator
Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compumedics Somnilink SPAP - Auto-titrating CPAP and Resmed Autoset S8 - Auto-titrating CPAP in people with Sleep Apnea, Obstructive, run by Compumedics Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment (time frame: Up to 8 weeks after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2012.