Obstructive Sleep Apnea Syndrome: Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device

Sleepinnov Technology

Status

Completed

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Device: Spiri+

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04141176

2018-A03014-51

Details and patient eligibility

About

Continuous Positive Airway Pressure (CPAP) is the reference treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS).This device functions as a pneumatic stent that stabilizes the upper airway, prevents periodic collapses during sleep.The correction of abnormal respiratory events during sleep allows improvement of symptoms related to OSAS and restores quality of life.The purpose of this study is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.

Full description

Obstructive sleep apnea syndrome (OSAS) is characterized by the repetitive occurrence of partial or complete pharyngeal obstructions during sleep.Continuous Positive Airway Pressure (CPAP) is the first line treatment of OSAS.

The aim of the prospective monocentric two steps pilot study SPIRI+ is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.

the first step will validate the capability of the algorithm to appropriately detect of abnormal repiratory events during sleep.the metrics will be a comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.
the second step will check overall clinical efficacy of the new CPAP device by assessing the percentage of OSAS with an index of residual events below 10 and 5 per hour.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

newly diagnosed and untreated Obstructive sleep apnea syndrome (IAH >15/hour) with an indication of treatment with CPAP
Patients who have given their informed written consent

Exclusion criteria