Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome (SENSAPNEA)

Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndrome, Obstructive
• Intervention / Treatment: Diagnostic test: Sunrise® solution; Diagnostic test: Polysomnography

Detailed Description

Sunrise® is a type IIa medical device with the CE label. It is a new home sleep technology, non-invasive, reliable and affordable by the patient.

The objective of this study is to evaluate the efficiency of the device in comparison with PSG for sleep apnea diagnosis.

40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution will provide the respiratory event index (REI) as well as the respiratory micro-arousals.

Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • University Hospital Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• Person in exclusion period for another study or participating in a medical study testing drugs.
• Subjects not being cooperative or respecting the study instructions, according the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunrise+PSG; 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® solution; Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.; Diagnostic test: Polysomnography; Gold standard method to diagnose SAS used as comparator; Other Names: PSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Sunrise® reproductibility on three consecutive nights	REI measured by Sunrise® on three consecutive nights	3 nights
Evaluation of the sleep quality: depth of sleep	Depth of sleep was assessed by the St Mary Hospital Questionnaire Q1 (scale from 1 "very light" to 8 "very depth"), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only	3 nights
Evaluation of the sleep quality: number of wake-ups	Number of Wake-ups was assessed by the St Mary Hospital Questionnaire Q2 (scale from 0 "no Wake-up" to 7 "more than 6 Wake-ups"), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only	3 nights
Evaluation of the sleep quality: sleep duration	Sleep duration was assessed by the St Mary Hospital Questionnaire Q3 (in hour), after one night without device, one night with PSG+Sunrise® and one night with Sunrise® only	3 nights

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Icadom; DOCAPOST; Sunrise
• Investigators: Principal Investigator: Jean Louis Pépin, MD, PhD, University Hospital Grenoble Alpes

Publications and helpful links

General Publications

• Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pépin 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Polysomnography; New medical device; Mandibular movement; Respiratory event index
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: 38RC19.358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No