Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sleepinnov Technology
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Part 1: Validation of algorithm detection of respiratory events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Part 1: Validation of algorithm detection of respiratory events
Time Frame: 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
Time Frame: baseline
Percentage of OSAS with an index of residual events below 10 and 5 per hour
Secondary Outcomes
- Part 1:(baseline)