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

LivaNova

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Kinesthetic stimulation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03300037

IAHO02

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• above 18 years.
• Patient with diagnosed severe obstructive sleep apnea syndrome (AHI > 30/h and > 80% of obstructive events diagnosed on polysomnography or polygraphy performed less than 6 months ago )
• Patient free from CPAP treatment or any other SAS treatment for at least 3 months
• Patient with stable psychotropic medication since the diagnostic polysomnography or polygraphy exam
• Patient has signed the informed consent

Exclusion criteria

• Patients sleeping less than 4 hours per night
• Patients suffering from respiratory failure or periodic breathing (cheynes stokes)
• Obese patient (BMI>40kg/m2)
• Diabetic patient with autonomic dysfunction
• Vulnerable patient in accordance with article L1121-6 of CSP
• Patient with progressive malignant pathology
• Patient already involved in another clinical study that could affect the result of this study
• Pregnant patient