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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults: Randomised Non-inferiority Double Blinded Trial.
Secondary ID [1] 0 0
10244A
Secondary ID [2] 0 0
SPAP001
Universal Trial Number (UTN)
Trial acronym
APAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment
Timepoint [1] 0 0
Up to 8 weeks after study completion
Secondary outcome [1] 0 0
AHI difference between test treatment and baseline
Timepoint [1] 0 0
Up to 8 weeks after study completion
Secondary outcome [2] 0 0
Arousal Index (AI) differences between the test and reference APAP treatments and between the test treatment and baseline
Timepoint [2] 0 0
Up to 8 weeks after study completion
Secondary outcome [3] 0 0
Respiratory Disturbance Index (RDI) differences between the test and reference APAP treatments and between the test treatment and baseline
Timepoint [3] 0 0
Up to 8 weeks after study completion
Secondary outcome [4] 0 0
Sleep Efficiency (SE) differences between the test and reference APAP treatments and between the test treatment and baseline
Timepoint [4] 0 0
Up to 8 weeks after study completion
Secondary outcome [5] 0 0
Oxygen desaturation index (DI) differences between the test and reference APAP treatments and between the test treatment and baseline
Timepoint [5] 0 0
Up to 8 weeks after study completion
Secondary outcome [6] 0 0
Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments.
Timepoint [6] 0 0
The patients fill KSS questionnaire immediately after each PSG study
Secondary outcome [7] 0 0
Test treatment AHI
Timepoint [7] 0 0
Up to 8 weeks after study completion

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Department of Respiratory & Sleep Medicine, Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Compumedics Limited
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01210261
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Garun Hamilton, PhD
Address 0 0
Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01210261