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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-16

Study Completion Date

2020-06-23

Brief Summary

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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©.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

It's a prospective, open, monocentric study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spiri+

new CPAP device

Group Type EXPERIMENTAL

Spiri+

Intervention Type 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.

Interventions

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Spiri+

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No