HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
NCT ID: NCT03300037
Last Updated: 2017-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2014-09-01
2015-04-16
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Kinesthetic stimulation
The kinesthetic actuator is placed on the skin near the ear and emits vibrations.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
LivaNova
INDUSTRY
Responsible Party
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Locations
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CHU Angers
Angers, , France
Laboratoire du sommeil et d'EFCR; Hopital Michallon
Grenoble, , France
CHU Montpellier
Montpellier, , France
CHU Rennes
Rennes, , France
University Hospital Tours
Tours, , France
Countries
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Other Identifiers
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IAHO02
Identifier Type: -
Identifier Source: org_study_id