The feasibility of the new device is investigated. The primary objective includes the ability to regulate nocturnal PETCO2 in patients with CSAS and the user experiences. Secondary objectives concern the differences in CSAS parameters, e.g. apnea/…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
Central sleep apnea syndrome (CSAS) is a sleep related breathing disorder based
on a disturbed respiratory regulation. This regulation is predominantly based
on the partial pressure of carbon dioxide of the arterial blood (PaCO2). A
disturbance in PaCO2 can result in Cheyne Stokes respiration (CSR); the
alternation of hyperventilation and apneas. Symptoms include sleep disruption,
excessive daytime sleepiness and insomnia. Current treatment is continuous
positive airway pressure (CPAP) therapy, although for many patients it seems
not effective enough. Several studies are performed to investigate an
alternative method to treat CSAS. Supplementary carbon dioxide (CO2) seems
effective. Dynamic setups have benefit over static ones, since the CO2 can be
closely controlled. In addition, the use of dead space or rebreathing is
preferred over gas mixers, because gas mixers are expensive and inhalation of
excessive CO2 is imminent. A new setup is developed to regulate the pressure of
end tidal CO2 (PETCO2) by means of dynamic rebreathing, without the use of gas
mixers.
Study objective
The feasibility of the new device is investigated. The primary objective
includes the ability to regulate nocturnal PETCO2 in patients with CSAS and the
user experiences. Secondary objectives concern the differences in CSAS
parameters, e.g. apnea/hypopnea index (AHI), CSR, arousal index (AroI) and loop
gain.
Study design
This is a feasibility study with a novel intervention.
Intervention
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 and a valve system to be
able to regulate the partition of room air and rebreathed air. The regulation
is based on real time measurement of PETCO2. A reference PSG (usual care) is
used to measure PETCO2 during the night while only room air is inhaled, to
determine the target PETCO2 and associate range. Dynamic rebreathing with the
new setup takes place to regulate PETCO2 during the second PSG.
Study burden and risks
With elevation of PaCO2 sympathetic nerve activity can occur. It is however
intended to regulate and stabilize PaCO2. With malfunctioning of the new device
inhalation of excessive CO2 is imminent, this risk is minimalised to closely
monitor the patient and parameter values during the night. On top of that, the
patient is always able to breathe in room air through the mouth when necessary.
Whenever the PETCO2 increases over 7.5 kPa or SpO2 < 80% for longer than 30
minutes or an event (e.g. severe arrythmias) requiring immediate intervention.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
*18 years of age
Hypocapnic central sleep apnea syndrome (CSAS) (i.e. AHI* 15, *50% central events, central apnea index *5, presence of > 15% Cheyne Stokes respiration(CSR))
Written informed consent 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 sleep (according to CPAP read-out or their own / partner*s experience)
Pregnant women
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65541.044.18 |
| Other | NL7633 |
| OMON | NL-OMON27892 |