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

Primary Purpose

Sleep Apnea Syndrome, Obstructive

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sunrise® solution
Polysomnography
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea Syndrome, Obstructive focused on measuring New medical device, Mandibular movement, Respiratory event index, Polysomnography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Grenoble Alpes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunrise+PSG

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluation of the Sunrise® reproductibility on three consecutive nights
REI measured by Sunrise® on three consecutive 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
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
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

Full Information

First Posted
February 4, 2020
Last Updated
October 15, 2020
Sponsor
University Hospital, Grenoble
Collaborators
Sunrise, Icadom, DOCAPOST
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1. Study Identification

Unique Protocol Identification Number
NCT04262557
Brief Title
Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome
Acronym
SENSAPNEA
Official Title
Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Sunrise, Icadom, DOCAPOST

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Obstructive
Keywords
New medical device, Mandibular movement, Respiratory event index, Polysomnography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunrise+PSG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sunrise® solution
Intervention Description
Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.
Intervention Type
Diagnostic Test
Intervention Name(s)
Polysomnography
Other Intervention Name(s)
PSG
Intervention Description
Gold standard method to diagnose SAS used as comparator
Primary Outcome Measure Information:
Title
The performance of Sunrise® to detect the respiratory event index (REI)
Description
Evaluation of the correlation between Sunrise® and PSG for the estimation of the REI
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Evaluation of the Sunrise® reproductibility on three consecutive nights
Description
REI measured by Sunrise® on three consecutive nights
Time Frame
3 nights
Title
Evaluation of the sleep quality: depth of sleep
Description
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
Time Frame
3 nights
Title
Evaluation of the sleep quality: number of wake-ups
Description
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
Time Frame
3 nights
Title
Evaluation of the sleep quality: sleep duration
Description
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
Time Frame
3 nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis Pépin, MD, PhD
Organizational Affiliation
University Hospital Grenoble Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble Alpes
City
Grenoble
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35368281
Citation
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.
Results Reference
derived

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Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

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