Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Continuous positive airway pressure
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.
Interventions
DEVICESpiri+
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.
Sponsors
University Hospital, Grenoble
ICUREsearch
Sleepinnov Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
It's a prospective, open, monocentric study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Validation of algorithm detection of respiratory events | baseline | Comparison of the total number of events detected by the CPAP Sleepinnov© with data arising from a concurrent polysomnography. |
| Part 2: Validation of overall clinical efficacy | baseline | Percentage of OSAS with an index of residual events below 10 and 5 per hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: | baseline | Compare the different types of events detected by the Spiri + CPAP algorithm to the concomitant respective indices scored during concurrent |
Countries
France
Outcome results
None listed