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NCT Number: NCT04141176

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

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©.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

La Tronche, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spiri+

Device

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.

Primary outcomes

  1. 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.

  2. 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

  1. Part 1:

    Time frame: baseline

    Compare the different types of events detected by the Spiri + CPAP algorithm to the concomitant respective indices scored during concurrent

Sponsors and collaborators

Lead sponsor

Sleepinnov Technology

Industry

Collaborators

  • ICUREsearch
  • University Hospital, Grenoble

Registry information

Official study title

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

Acronym: Spiri+

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2019
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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