NCT04262557

Brief Summary

Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis. The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

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

February 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

February 4, 2020

Last Update Submit

October 15, 2020

Conditions

Sleep Apnea Syndrome, Obstructive

Keywords

New medical deviceMandibular movementRespiratory event indexPolysomnography

Outcome Measures

Primary Outcomes (1)

  • The performance of Sunrise® to detect the respiratory event index (REI)

    Evaluation of the correlation between Sunrise® and PSG for the estimation of the REI

    1 night

Secondary Outcomes (4)

  • Evaluation of the Sunrise® reproductibility on three consecutive nights

    3 nights

  • Evaluation of the sleep quality: depth of sleep

    3 nights

  • Evaluation of the sleep quality: number of wake-ups

    3 nights

  • Evaluation of the sleep quality: sleep duration

    3 nights

Study Arms (1)

Sunrise+PSG

EXPERIMENTAL

PSG and Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.

Diagnostic Test: Sunrise® solutionDiagnostic Test: Polysomnography

Interventions

Sunrise® solutionDIAGNOSTIC_TEST

Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.

Sunrise+PSG
PolysomnographyDIAGNOSTIC_TEST

Gold standard method to diagnose SAS used as comparator

Also known as: PSG
Sunrise+PSG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suspected to have a sleep apnea syndrome (Berlin score≥2)
  • Able to use a smartphone application
  • Be legally able to give consent
  • Person affiliated to social security

You may not qualify if:

  • Patients already treated for SAS
  • Patients suffering from a chronic obstructive or restrictive pulmonary disease with or without oxygen.
  • Patients suffering from a unstable cardiovascular disease or a severe heart failure requiring an hospitalzation in the previous three months or conform with the New York Heart Association criteria for class II or III diseases
  • Patients treated with myorelaxant medicines
  • Patients with a long beard disabling the setting of the mandibular sensor
  • Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.
  • Subjects not being cooperative or respecting the study instructions, according the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble Alpes

Grenoble, France

Location

Related Publications (1)

  • Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022.

    PMID: 35368281DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jean Louis Pépin, MD, PhD

    University Hospital Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 10, 2020

Study Start

May 18, 2020

Primary Completion

September 28, 2020

Study Completion

September 28, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)