Clinical trial NCT01405313: Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
Official title: Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodic Breathing
Breathing-Related Sleep Disorder
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Adaptive servoventilation (ASV) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. Previous studies in the field have shown that treatment of periodic breathing with ASV improves sleep quality and quality of life. In reducing central apneas, ASV reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (REM) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. ASV can also more effectively reduce central apnea and overall apnea/hypopnea index (AHI) in patients on long-term opiates, and appears to effectively treat Complex Sleep Apnea Syndrome. It is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated.

This is a prospective, randomised, crossover, observational study. Subjects will spend one night on conventional ASV and one night on modified ASV with full in-lab polysomnography (PSG) during therapy on both nights.

Objective and subjective parameters will be recorded and analysed.

Eligibility criteria: Inclusion Criteria:

* 21+ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Apnea/Hypopnea Index (AHI)
timeFrame: One night
Secondary outcomes:
measure: Oxygen Desaturation Index (ODI)
timeFrame: One night
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Centre, Ruhr University Bochum
state: North Rhine Westphalia
Study officials:
affiliation: Heart and Diabetes Centre, Ruhr University Bochum
name: Olaf Oldenburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.