Sleep Apnea, Obstructive Clinical Trial
Official title:
HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
The HYPNOS study is an acute feasibility study to validate a new device for automatic
detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system
and it will perform the following tasks:
- Detect apneas and hypopneas in real time, based on physiological signals acquired with a
cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))
- Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of
mechanoreceptors of the skin close to the mastoid bone
The primary objective is to verify that the PASITHEA system is able to detect apneas and
hypopneas reliably.
The main secondary objective of the study is to assess the effect of kinesthetic stimulation
on reducing the number of sleep respiratory disorders.
Another objective of the study is to verify the safety of the PASITHEA system.
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