Clinical trial NCT03300037: HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
Official title: HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Grenoble
First posted: 2017-10-03
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe untreated obstructive SAS patients

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 night
Secondary outcomes:
measure: Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011
timeFrame: 1 night
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Grenoble
country: France
facility: Laboratoire du sommeil et d'EFCR; Hopital Michallon
city: Montpellier
country: France
facility: CHU Montpellier
city: Rennes
country: France
facility: CHU Rennes
city: Tours
country: France
facility: University Hospital Tours
Study officials:
References: