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

NCT04141176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-08-25

No results posted yet for this study

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©.

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER

  • ICUREsearch

    collaborator INDUSTRY

  • Sleepinnov Technology

    lead INDUSTRY

Principal Investigators

  • Renaud Tamisier, PhD · University Hospital, Grenoble

  • Jean-Louis Pépin, PhD · University Hospital, Grenoble

  • Marie Destors, MD · University Hospital, Grenoble

  • Sébastien Baillieul, MD · University Hospital, Grenoble

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-16
Primary Completion
2020-06-23
Completion
2020-06-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141176 on ClinicalTrials.gov