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NCT Number: NCT04262557

Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome

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.

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Key information

Conditions

Sleep Apnea Syndrome, Obstructive 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble Alpes

Grenoble, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Sunrise® solution

Diagnostic Test

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

Polysomnography

Diagnostic Test

Gold standard method to diagnose SAS used as comparator

Other names: PSG

Primary outcomes

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

    Time frame: 1 night

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

Secondary outcomes

  1. Evaluation of the Sunrise® reproductibility on three consecutive nights

    Time frame: 3 nights

    REI measured by Sunrise® on three consecutive nights

  2. Evaluation of the sleep quality: depth of sleep

    Time frame: 3 nights

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

    Time frame: 3 nights

    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

  4. Evaluation of the sleep quality: sleep duration

    Time frame: 3 nights

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • DOCAPOST
  • Icadom
  • Sunrise

Registry information

Official study title

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

Acronym: SENSAPNEA

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Oct 19, 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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