Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

Periodic Breathing Clinical Trial

Official title:

Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01405313
• Other study ID #: MA231210
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2011
• Last updated: March 13, 2012
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: ResMed
• Contact: Olaf Oldenburg, MD
• Phone: +49 (0) 5731 97 1258
• Email: ooldenburg[@]hdz-nrw.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breathing-Related Sleep Disorder
• Parasomnias
• Periodic Breathing
• Respiratory Aspiration
• Sleep Disorders

Intervention

Device:
• Modified Adaptive Servoventilation Device
The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
• Conventional Adaptive Servoventilation device
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.

Locations

Country	Name	City	State
Germany	Heart and Diabetes Centre, Ruhr University Bochum	Bad Oeynhausen	North Rhine Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View 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. Epub 2003 Aug 19. — View Citation

Schädlich S, Königs I, Kalbitz F, Blankenburg T, Busse HJ, Schütte 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. German. — View Citation

Teschler H, Döhring 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two nights	No
Secondary	Oxygen desaturation index (ODI)	Oxygen desaturation index based on SpO2 measurement of number of dips per hour of sleep will be recorded, analysed and reported.	Two nights	No