NCT03300037

HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	Kinesthetic stimulation	The kinesthetic actuator is placed on the skin near the ear and emits vibrations.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-04-16
• Completion: 2015-04-16
• First posted: 2017-10-03
• Last updated: 2017-10-03

Locations

5 sites across 1 country: France