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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01210261
Registration number
NCT01210261
Ethics application status
Date submitted
23/09/2010
Date registered
28/09/2010
Date last updated
5/04/2012
Titles & IDs
Public title
New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults
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Scientific title
New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults: Randomised Non-inferiority Double Blinded Trial.
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Secondary ID [1]
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10244A
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Secondary ID [2]
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SPAP001
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Universal Trial Number (UTN)
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Trial acronym
APAP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Compumedics Somnilink SPAP - Auto-titrating CPAP
Treatment: Devices - Resmed Autoset S8 - Auto-titrating CPAP
Active Comparator: Autoset S8 - Single night auto-titrating CPAP treatment using the reference device (Resmed Autoset S8) with polysomnographic monitoring
Experimental: Somnilink SPAP - Single night auto-titrating CPAP treatment using the test device with polysomnographic monitoring
Treatment: Devices: 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.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment
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Assessment method [1]
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AHI is the number of apnea and hypopnea events per hour of sleep
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Timepoint [1]
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Up to 8 weeks after study completion
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Secondary outcome [1]
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AHI difference between test treatment and baseline
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Assessment method [1]
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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
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Timepoint [1]
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Up to 8 weeks after study completion
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Secondary outcome [2]
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Arousal Index (AI) differences between the test and reference APAP treatments and between the test treatment and baseline
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 8 weeks after study completion
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Secondary outcome [3]
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Respiratory Disturbance Index (RDI) differences between the test and reference APAP treatments and between the test treatment and baseline
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 8 weeks after study completion
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Secondary outcome [4]
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Sleep Efficiency (SE) differences between the test and reference APAP treatments and between the test treatment and baseline
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 8 weeks after study completion
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Secondary outcome [5]
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Oxygen desaturation index (DI) differences between the test and reference APAP treatments and between the test treatment and baseline
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 8 weeks after study completion
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Secondary outcome [6]
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Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments.
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Assessment method [6]
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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.
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Timepoint [6]
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The patients fill KSS questionnaire immediately after each PSG study
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Secondary outcome [7]
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Test treatment AHI
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Assessment method [7]
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The study will test the hypothesis of the test treatment AHI being below a threshold of 9 that is within the range 5-10.
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Timepoint [7]
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Up to 8 weeks after study completion
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2011
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Department of Respiratory & Sleep Medicine, Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Compumedics Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01210261
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Garun Hamilton, PhD
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Address
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Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01210261
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