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

Sleepinnov Technology20 enrolled

Overview

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©.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Spiri+DEVICE

CPAP Spiri+ will be weared during one night for each included patient.The validation of the CPAP Spiri+ algorithm will be in the first 10 patients and appreciation of overall clinical efficacy on the 10 last OSAS.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * Pregnant or lactating women * Patients not affiliated to the French social security system or equivalent * Patient deprived of liberty by judicial or administrative decision * Patients under guardianship or curatorship

Locations (1)

University Hospital Grenoble

La Tronche, France

Outcomes

Primary Outcomes

Part 1: Validation of algorithm detection of respiratory events

Comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography.

Time frame: baseline

Part 2: Validation of overall clinical efficacy

Percentage of OSAS with an index of residual events below 10 and 5 per hour

Time frame: baseline

Secondary Outcomes

Part 1:

Compare the different types of events detected by the Spiri + CPAP algorithm to the concomitant respective indices scored during concurrent

Time frame: baseline

Data from ClinicalTrials.gov

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