Dynamische regulatie van koolstofdioxide bij patiënten met centraal slaapapneu.

Conditions: Central sleep apnea - sleep disorder

Registration Number: NL-OMON27892

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

= 18 years of age
-Hypocapnic CSAS (i.e. AHI =15, = 50% central events, CAI = 5, presence of >15% Cheyne Stokes Respiration)
-Written informed consent (IC) from the subject prior to participation
-CPAP nasal mask use = 4 hours/night for = 5 days a week.

Exclusion Criteria

-Unable to understand and read the Dutch language
-Hypercapnia during daytime (PaCO2 = 6 kPa) and/or metabolic compensation (bicarbonate > 27 mmol/l)
-Hypercapnia during the reference PSG (mean PETCO2 = 6.3 kPa during N2 sleep excluded from CSR and apnea)
-History of neuro(muscular) disease and/or kyphoscoliosis
-NYHA Functional Classification class IV
-Chronic obstructive pulmonary disease stage 3 / 4 (GOLD-criteria)
-Drug abuse
-Use of drug with known influence on respiratory drive that cannot be stopped one week prior to the PSGs (e.g. analeptics and opioids)
-Patients breathing through the mouth during night (based on own experience or partner’s experience)
-Patients breathing through the mouth during sleep (according to CPAP read-out or their own / partner’s experience)
-Pregnant women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main study parameters are the ability to regulate PETCO2, quantified by the percentage of time spent in predetermined patient specific PETCO2 range, and the user experiences, quantified by a numeric rating scale based questionnaire.

Secondary Outcome Measures

Name	Time	Method
Secondary study parameters are the differences between the control night and intervention night of the following parameters: Apnea/hypopnea index (AHI) Central apnea/hypopnea index (CAHI) Central apnea index (CAI) Central hypopnea index (CHI) Arousal index (AroI) Mean ventilation (L/min) Percentage of total sleep time (TST) with oxygen desaturation (SpO2<90%) Total duration of CSR divided by TST Percentages of TST spent in each sleep stage (N1, N2, N3 and REM) Loop gain, defined as the hyperpnea length/cycle length of CSR.