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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: Kinesthetic stimulation

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• France
  • Angers, France, 49000
    • CHU Angers
  • Grenoble, France, 38043
    • Laboratoire du sommeil et d'EFCR; Hopital Michallon
  • Montpellier, France
    • CHU Montpellier
  • Rennes, France
    • CHU Rennes
  • Tours, France, 37 044
    • university hospital Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Severe untreated obstructive SAS patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011	All adverse events will be recorded and assessed according to ISO 14155, rev 2011	1 night

Collaborators and Investigators

• Sponsor: LivaNova
• Collaborators: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): April 16, 2015
• Study Completion (Actual): April 16, 2015

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: IAHO02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No