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Dynamische regulatie van koolstofdioxide bij patiënten met centraal slaapapneu.

The regulation of end-tidal carbon dioxide by dynamic rebreathing for patients with central sleep apnea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27892
Enrollment
5
Registered
2019-03-11
Start date
2019-04-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central sleep apnea - sleep disorder

Interventions

The intervention is the regulation of nocturnal PETCO2 during one night by means of a new setup based on literature. The dynamic rebreathing setup consists of a sealed CPAP masker, capnograph, tubes a

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactGerike Buitenhuis

Medische Spectrum Twente

gh.buitenhuis@mst.nl053 487 2000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)