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

NCT03300037 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2017-10-03

No results posted yet for this study

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

DEVICE

Kinesthetic stimulation

The kinesthetic actuator is placed on the skin near the ear and emits vibrations.

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER

  • LivaNova

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-01
Primary Completion
2015-04-16
Completion
2015-04-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03300037 on ClinicalTrials.gov