Central sleep apnoea/heart failure Nervous System Diseases Sleep disorders
Conditions
Interventions
Following an expiratory positive airway pressure (EPAP) determination study, subjects will be randomly assigned to one night of the new mode of Auto SV without Bi-Flex (ASV3 without Bi-Flex®), one nig
IPAPmin/IPAPmax = EPAP). These studies will be performed within 14 days of the EPAP determination study. There will be a fixed follow-up period of 3 months.
Sponsors
Philips Respironics (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Apnoea Hypopnoea Index (AHI) greater than 15 (greater than 50% central events including central hypopnoeas) confirmed by full polysomnography (PSG) within last 14 days 2. Heart failure due to ischaemic, non-ischaemic or hypertensive cardiomyopathy (New York Heart Association [NYHA] Class II or III) 3. Aged greater than or equal to 40 - less than or equal to 80 years, either sex 4. Objectively impaired left ventricular ejection fraction greater than or equal to 40%, assessed by echocardiography 5. Stable clinical status and stable optimal medical therapy according to the guidelines of the European Society of Cardiology for at least 4 weeks (www.escardio.org/knowledge/guidelines) 6. Able to provide consent 7. Able to follow the study protocol
Exclusion criteria
Exclusion criteria: 1. Positive airway pressure (PAP) therapy is otherwise medically contraindicated 2. Acute upper respiratory infection, encephalitis, sinusitis or middle ear infection or surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days 3. Drug abuse (both acute and chronic) according to the Drug Abuse Screening Test (DAST) criteria 4. Alcohol abuse (both acute and chronic) according to the CAGE criteria 5. Intake of opiods or central relevant drugs, sedatives, or other drugs which impair sleep 6. Psychiatric or neurological diseases resulting in impairment of sleep, therapy or compliance 7. Thyroidal dysfunction 8. Any chronic pain syndrome 9. Acute pulmonary, and other internal diseases 10. Chronic pulmonary and other internal diseases resulting in impairment of sleep 11. Untreated, non-obstructive sleep apnoea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic leg movements (PLM)/restless legs syndrome (RLS) 12. Previous exposure to positive airways pressure, bi-level or Auto SV therapy 13. Acute dermatitis or other skin lesions or trauma interfering with the application of a mask 14. Unwilling to participate in the study 15. Participation in another clinical study in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variables investigated will include: 1. AHI (total, rapid eye movement [REM] and non-rapid eye movement [NREM]) - total, obstructive, central, and mixed (apnoea only) events (apnoea and hypopnoea) 2. Respiratory Disturbance Index (RDI): AHI plus respiratory effort related arousals (RERAs) 3. Cheyne-Stokes Respiration (CSR) Index - total 4. Arousal Index - total, respiratory, RERA and movement related 5. Sleep latency 6. Total sleep time 7. Wake, stages N1, N2, N3 and R sleep (% total sleep time [TST]) 8. Wake, stages N1, N2, N3 and R sleep (in minutes) 9. REM latency 10. Number of REM periods 11. Mean REM interval 12. Mean pressure profile (EPAP, minimum inspiratory positive airway pressure [IPAPmin], maximum inspiratory positive airway pressure [IPAPmax]) 13. Leak profile All outcomes will be measured during each of the 3 therapy nights and on waking the following morning. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comfort will be improved on the new mode of Auto SV and further improved when Bi-Flex® is activated 2. Subjects will rank the new mode of Auto SV higher than the established mode in terms of preference and the new mode of Auto SV highest when Bi-Flex® is activated 3. The breathing event output from the new mode of Auto SV will result in an AHI (total) that is in diagnostic agreement with the apnoea-hypopnoea index obtained from a full clinical PSG All outcomes will be measured during each of the 3 therapy nights and on waking the following morning. | — |
Countries
Germany, United Kingdom
Outcome results
None listed