Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Compumedics Limited
ClinicalTrials.gov Identifier:
NCT01210261
First received: September 23, 2010
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Device: Compumedics Somnilink SPAP - Auto-titrating CPAP
Device: Resmed Autoset S8 - Auto-titrating CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults: Randomised Non-inferiority Double Blinded Trial.

Resource links provided by NLM:


Further study details as provided by Compumedics Limited:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI) difference between test and reference APAP treatment [ Time Frame: Up to 8 weeks after study completion ] [ Designated as safety issue: No ]
    AHI is the number of apnea and hypopnea events per hour of sleep


Secondary Outcome Measures:
  • AHI difference between test treatment and baseline [ Time Frame: Up to 8 weeks after study completion ] [ Designated as safety issue: No ]

    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


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • Karolinska Sleepiness Scale (KSS) difference between the test and reference APAP treatments. [ Time Frame: The patients fill KSS questionnaire immediately after each PSG study ] [ Designated as safety issue: No ]
    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.

  • Test treatment AHI [ Time Frame: Up to 8 weeks after study completion ] [ Designated as safety issue: No ]
    The study will test the hypothesis of the test treatment AHI being below a threshold of 9 that is within the range 5-10.


Enrollment: 30
Study Start Date: May 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Somnilink SPAP

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210261

Locations
Australia, Victoria
Department of Respiratory & Sleep Medicine, Monash Medical Centre
Clayton, Victoria, Australia, 3168
Sponsors and Collaborators
Compumedics Limited
Investigators
Principal Investigator: Garun Hamilton, PhD Director of Sleep Research, Department of Respiratory & Sleep Medicine, Monash Medical Centre
  More Information

No publications provided

Responsible Party: Compumedics Limited
ClinicalTrials.gov Identifier: NCT01210261     History of Changes
Other Study ID Numbers: SPAP001, 10244A
Study First Received: September 23, 2010
Last Updated: April 3, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Compumedics Limited:
OSA
CPAP
APAP
SPAP
Obstructive Sleep Apnea
Sleep Apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014