Alternative APAP Method for Non-invasive Positive Airway Pressure Therapy in OSAHS patients.
Amendment: Mallampati score as a predictor for effective Positive Airway Pressure

Obstructive Sleep Apnea-Hypopnoea Syndrome (OSAHS) is characterized by
repetitive episodes of airflow reduction due to pharyngeal narrowing. The lack
of adequate alveolar ventilation results in oxygen desaturation. This
desaturation is resolved by an arousal from deep sleep to reopen the airway.
The mainstay of medical treatment of OSAHS is administration of non-invasive
positive airway pressure (PAP) therapy during sleep. Two kinds of PAP devices
are available, the continuous PAP (CPAP) device and the auto-adjusted PAP
(APAP) pressure.

The intention is to reduce mean applied pressures during the night which could
increase acceptance and adherence with chronic PAP treatment. The pressure can
be decreased by restricting the APAP pressure range around the effective
pressure range.

In literature hardly any research is done to restrict the APAP (RAPAP)
pressure. In this study the hypothesis is tested, if a new adjusted mode of
APAP can approach an effective pressure range of limited APAP pressures to
lower the mean applied pressure so adherence and acceptance will increase, and
adverse effects will decrease. By comparison of a fixed CPAP mode with a
restricted APAP range, this study aims to improve subjective and objective
sleep parameters in OSAHS patients.

Amendment: Mallampati score is a well-known predictor for the development of
sleep apnea. The same applies for the availability of retrognathia. It is very
likely that these factors can tell us something about the amount of pressure
that is needed to treat patients with sleep apnea.

1. To investigate whether an adjusted mode of APAP can improve patients
adherence in comparison to fixed CPAP in present-day PAP therapy of OSAHS
patients.
2. To investigate the agreement between the parameters of the CPAP devices and
the polygraphy measurement with CPAP.


Amendment: Find out if Mallampati score and retrognathia are factors that
combined with BMI, neck circumference and amount of breathing cessations an
hour, can predict the effective treatment pressure for sleep apnea patients.

The design of this study will be a single centre cross-over single blind study
at the Medisch Spectrum Twente locations Enschede and Oldenzaal.

Participating subjects will receive randomly two modes of PAP-therapy. One PAP
mode will be given constant pressure (CPAP) and the other mode will deliver
restricted APAP treatment (RAPAP). Both treatment modes will be delivered with
the same REMstar Auto. The initial pressure level of the PAP-therapy is derived
from manual CPAP titration polysomnography.

Amendment: The same population group will come to the hospital once again and
the Mallampati score and availability of retrognathia is scored. Also a digital
photograph is taken to ensure digital comparison and to express Mallampati
score in surface units and retrognathia in distance instead of just positive or
negative.

The risk for adverse events in this study is negligible. The CPAP treatment is
conducted for years at mild to severe OSAS patients without occurrence of any
(serious) adverse events. The operational algorithms are identical in their
pressure adjustment even despite the adjustments made in the RAPAP mode. The
pressure adjustment is limited to the range of pressures that is indicated.
Since the range is smaller than the APAP, we do not suspect any risks.