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

Obstructive Sleep Apnea Syndrome Clinical Trial

— Spiri+  

Official title:

Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141176
• Other study ID #: 2018-A03014-51
• Status: Completed
• Phase: N/A
• Start date: November 16, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: November 2019
• Source: Sleepinnov Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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©.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 23, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	University Hospital Grenoble	La Tronche

Sponsors (3)

Lead Sponsor	Collaborator
Sleepinnov Technology	ICUREsearch, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

Lévy P, Kohler M, McNicholas WT, Barbé F, McEvoy RD, Somers VK, Lavie L, Pépin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	Part 2: Validation of overall clinical efficacy	Percentage of OSAS with an index of residual events below 10 and 5 per hour	baseline
Secondary	Part 1:	Compare the different types of events detected by the Spiri + CPAP algorithm to the concomitant respective indices scored during concurrent	baseline