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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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesthetic stimulation

Device

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

Primary outcomes

Performance of real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events.

Time frame: 1 night

During the night of the recording, the PASITHEA system and the PSG will be positioned in parallel. PSG-scored events will be matched with the output of the real-time detector: a true positive event is defined as an event detected less than 10 seconds before or within the duration of a PSG-annotated events. Apneas detected as hypopneas (and reciprocally) will be regarded as true positives. Sensitivity and positive predictive value will be calculated as per conventional definintion and the 9% confidence interval will be calculated using the Wilson score.

Secondary outcomes

Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011

Time frame: 1 night

All adverse events will be recorded and assessed according to ISO 14155, rev 2011

Sponsors and collaborators

Lead sponsor

LivaNova

Industry

Collaborators

University Hospital, Grenoble

Registry information

Acronym: HYPNOS

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 3, 2017
Registry last updated: Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed