Indications For Use - Sibelmed Somnibel Pro Manuel D'utilisateur

somnibel Pro
User's Manual

1.2 INDICATIONS FOR USE

It is well known that more than 50% of SAHS patients experience a worsening in the frequency and severity of
respiratory events when sleeping in the supine position, compared to other body positions . This positional
1, 2, 3, 4
dependency is more prevalent in mild to moderate, younger and less obese patients, which are the majority
of the total population of SAHS patients . Positional SAHS is defined as an abnormal Apnea-Hyponea Index
5, 6, 7
(AHI) that is double in supine position compared to other positions . Additionally, the severity and frequency
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of snoring is also positional dependant in the majority of habitual snoring subjects . When the supine position
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is avoided, the frequency of respiratory events is reduced in patients with positional Obstructive Sleep Apnea
(OSA) and positional therapy is considered an effective treatment for OSA in selected patients .
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Somnibel Pro
is a body-worn, active device aimed exclusively for medical staff at evaluating the efficacy of
positional therapy in patients with SAHS or with habitual snoring and at its follow-up. It is able to detect the
position of the patient during sleep, to generate a gentle vibration, depending on the detected position, that induces
the patient to change his/her position and to record signals and compliance data for their subsequent analysis.
Somnibel Pro
can be placed at the forehead or chest of the patient while lying down to sleep. In both placements,
the device vibration is able to induce a position change and, consequently, a reduction of respiratory events.
Somnibel Pro
records the body position, actigraphy and stimulus power signals for up to 36 treatment sessions
and the number of device uses for up to 365 days. These signals can be downloaded to a personal computer
for monitoring the patient behavior during the night, evaluating the efficacy of treatment and following-up the
Somnibel Pro
therapy compliance. Additionally, includes several compliance enhancement features that can be
configured from the personal computer for adapting the treatment settings to each patient's needs. The use of
Somnibel Pro has proven to be effective in reducing the AHI and the time in supine position and in improving
the oxygen saturation, without affecting the quantity nor quality of sleep in patients with positional OSA .
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Somnibel Pro
is also designed for allowing the performance of clinical studies since it includes two functioning
Somni Lab Somni Lab
modes (therapy and placebo) that can be configured thought the software. Consult the
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