Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

NCT01405313 | Completed Results

• 1 other identifier: MA231210
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.

Conditions

Periodic Breathing; Breathing-Related Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Apnea/Hypopnea Index (AHI)

  Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by \>90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by \>30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.

  One night

Secondary Outcomes (1)

• Oxygen Desaturation Index (ODI)

  One night

Study Arms (2)

Modified ASV

EXPERIMENTAL

Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.

Device: Modified Adaptive Servoventilation Device

Conventional ASV

ACTIVE COMPARATOR

Conventional ASV This is the current (predicate) ASV algorithm.

Device: Conventional Adaptive Servoventilation device

Interventions

Modified Adaptive Servoventilation Device DEVICE

The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.

Also known as: ResMed Enhanced ASV, ASVAuto

Modified ASV

Conventional Adaptive Servoventilation device DEVICE

Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.

Also known as: ResMed AutoSet CS2, ResMed VPAP Adapt SV, ResMed S9 VPAP Adapt

Conventional ASV

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• Chronic ResMed ASV therapy patient
• Current ASV therapy for at least 4 weeks
• Able to understand fully the study information and participation requirements
• Provide signed informed consent

You may not qualify if:

• Acute cardiac decompensation
• Acute myocardial infarction within last 3 months
• Resuscitation within last 3 months
• Stroke with swallowing disorders or persistent hemiparesis
• Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed
• Untreated restless legs syndrome
• Alcohol or drug abuse
• Known cancer
• Pregnancy
• Conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Heart and Diabetes Centre, Ruhr University Bochum

Bad Oeynhausen, North Rhine-Westphalia, D-32545, Germany

Location

Related Publications (6)

• Teschler H, Dohring J, Wang YM, Berthon-Jones M. Adaptive pressure support servo-ventilation: a novel treatment for Cheyne-Stokes respiration in heart failure. Am J Respir Crit Care Med. 2001 Aug 15;164(4):614-9. doi: 10.1164/ajrccm.164.4.9908114.

  PMID: 11520725 BACKGROUND

• Pepperell JC, Maskell NA, Jones DR, Langford-Wiley BA, Crosthwaite N, Stradling JR, Davies RJ. A randomized controlled trial of adaptive ventilation for Cheyne-Stokes breathing in heart failure. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1109-14. doi: 10.1164/rccm.200212-1476OC. Epub 2003 Aug 19.

  PMID: 12928310 BACKGROUND

• Schadlich S, Konigs I, Kalbitz F, Blankenburg T, Busse HJ, Schutte W. [Cardiac efficiency in patients with Cheyne-Stokes respiration as a result of heart insufficiency during long-term nasal respiratory treatment with adaptive servo ventilation (AutoSet CS)]. Z Kardiol. 2004 Jun;93(6):454-62. doi: 10.1007/s00392-004-0083-3. German.

  PMID: 15252739 BACKGROUND

• Oldenburg O, Schmidt A, Lamp B, Bitter T, Muntean BG, Langer C, Horstkotte D. Adaptive servoventilation improves cardiac function in patients with chronic heart failure and Cheyne-Stokes respiration. Eur J Heart Fail. 2008 Jun;10(6):581-6. doi: 10.1016/j.ejheart.2008.04.007. Epub 2008 May 16.

  PMID: 18486550 BACKGROUND

• Javaheri S, Malik A, Smith J, Chung E. Adaptive pressure support servoventilation: a novel treatment for sleep apnea associated with use of opioids. J Clin Sleep Med. 2008 Aug 15;4(4):305-10.

  PMID: 18763420 BACKGROUND

• Oldenburg O, Spiesshofer J, Fox H, Prib N, Horstkotte D. Performance of conventional and enhanced adaptive servoventilation (ASV) in heart failure patients with central sleep apnea who have adapted to conventional ASV. Sleep Breath. 2015 Sep;19(3):795-800. doi: 10.1007/s11325-014-1083-9. Epub 2014 Nov 21.

  PMID: 25413958 RESULT

Limitations and Caveats

None to report

Results Point of Contact

• Title: Director Medical Affairs
• Organization: ResMed

adamb@resmed.com.au

+6128841000

Study Officials

• Olaf Oldenburg, MD

  Heart and Diabetes Centre, Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 29, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2012-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)