Clinical trial NCT04141176: Obstructive Sleep Apnea Syndrome: Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device
Official title: Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Continuous positive airway pressure
Lead sponsor: Sleepinnov Technology
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Grenoble
name: ICUREsearch
First posted: 2019-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It's a prospective, open, monocentric study.
Primary purpose: TREATMENT

Brief summary: 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©.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Part 1: Validation of algorithm detection of respiratory events
timeFrame: baseline
measure: Part 2: Validation of overall clinical efficacy
timeFrame: baseline
Secondary outcomes:
measure: Part 1:
timeFrame: baseline
Other outcomes:
Locations:
city: La Tronche
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Renaud Tamisier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Jean-Louis Pépin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Marie Destors, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: Sébastien Baillieul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.
citation: Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.