NCT04141176

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©.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

November 16, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
Last Updated

August 25, 2020

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

October 24, 2019

Last Update Submit

August 24, 2020

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Continuous positive airway pressure

Outcome Measures

Primary Outcomes (2)

  • 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

  • Part 2: Validation of overall clinical efficacy

    Percentage of OSAS with an index of residual events below 10 and 5 per hour

    baseline

Secondary Outcomes (1)

  • Part 1:

    baseline

Study Arms (1)

Spiri+

EXPERIMENTAL

new CPAP device

Device: Spiri+

Interventions

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.

Spiri+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

La Tronche, 38700, France

Location

Related Publications (2)

  • 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.

    PMID: 27568340BACKGROUND

  • Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.

    PMID: 27188535BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Renaud Tamisier, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • Jean-Louis Pépin, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • Marie Destors, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • Sébastien Baillieul, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: It's a prospective, open, monocentric study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

November 16, 2019

Primary Completion

June 23, 2020

Study Completion

June 23, 2020

Last Updated

August 25, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)