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Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis (SUNSAS)

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ClinicalTrials.gov Identifier: NCT05057975
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : March 18, 2022
Sponsor:
Collaborator:
ICUREsearch
Information provided by (Responsible Party):
Sunrise

Brief Summary:
Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm, open-label, multicenter, national, controlled study.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Sunrise Device: polysomnography Not Applicable

Detailed Description:

The new Sunrise integrated digital solution is a disposable 3 gram sensor that sits on the chin for sleep disorders diagnosis. This device records mandibular movements, head movements and position during sleep. Data acquisition is done through a mobile application installed on the user smartphone. Data is then transferred automatically at the end of the test (overnight) to a cloud platform where it is automatically analyzed. The Health Care Professional (HCP) and the patient have access to sleep parameters and report.

The objective of this trial is to determine the place of the Sunrise device in the care pathway in France for patients suspected of having OSA. The assumption is that Sunrise is both non-inferior to the normal practice (i.e., the PSG) on sleepiness at 3 months post-diagnosis, and superior to the PSG (outpatient or in-lab) in terms of time between inclusion and diagnosis appointment and treatment initiation. By speeding up the treatment initiation, the hypothesis is that Sunrise is also superior to the PSG on sleepiness as well as quality of life and work productivity at 3 months post-inclusion. Another assumption is that Sunrise is non-inferior to the PSG on CPAP compliance at 3 months following treatment initiation.

The SUNSAS study will be launched in 14 centers (public and private) in France and will include 848 patients aged 18 to 80 years. Eligible patients will be included and randomized in 2 arms, i.e., the Sunrise arm and the PSG arm. An appointment to discuss the diagnosis and treatment options (for patients suffering from OSA) will be arranged after the procedure (PSG or Sunrise) is performed. On site follow-up visits will be then organized at 3 months post-inclusion and at 3 months post-diagnosis, and a phone call will be scheduled at 3 months post-treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 848 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, controlled, randomized, parrallel, open label, multicenter and national
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation d'Une Solution Digitale intégrée (SUNrise®) d'Analyse Automatique Des Mouvements Mandibulaires Par Intelligence Artificielle Versus Polysomnographie Pour le Diagnostic du Syndrome d'Apnées Obstructives du Sommeil
Actual Study Start Date : October 28, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Sunrise
Home Sleep Test, OSA diagnosis based on mandibular movements recording
Device: Sunrise
Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.

Active Comparator: PSG
Polysomnography, OSA diagnosis based on local scoring by center
Device: polysomnography
Reference protocol to diagnose OSA (in-lab or outpatient PSG)




Primary Outcome Measures :
  1. Change in daily sleepiness [ Time Frame: 3 months post-diagnosis ]

    To determine the non-inferiority of Sunrise vs PSG on sleepiness at 3 months post-diagnosis using the Epworth Sleepiness Scale (ESS) score.

    The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher the average sleep propensity in daily life.


  2. Time to diagnosis [ Time Frame: Up to 12 months ]
    To determine the superiority of Sunrise vs PSG in terms of time between inclusion and diagnosis appointment

  3. Time to treatment [ Time Frame: Up to 15 months ]
    To determine the superiority of Sunrise vs PSG in terms of time between inclusion and treatment initiation

  4. Change in daily sleepiness [ Time Frame: 3 months post inclusion ]
    To determine the superiority of Sunrise vs PSG on sleepiness at 3 months post-inclusion using ESS


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: 3 months post inclusion visit ]
    To determine the superiority of Sunrise vs PSG on quality of life at 3 months post-inclusion using Short Form 36 (SF-36) SF-36 is a 0-100 scale score, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  2. Change in quality of life [ Time Frame: 3 months post inclusion visit ]

    To determine the superiority of Sunrise vs PSG on quality of life at 3 months post-inclusion using Quebec Sleep Questionnaire (QSQ).

    QSQ utilizes 32 items to measure 5 domains: daytime sleepiness, diurnal symptoms, nocturnal symptoms, emotions, and social interactions.Item scores range from 1 to 7. Mean scores for each domain are calculated, and a total score is derived by calculating the mean of all items. Higher scores are associated with better better quality of life.


  3. Change in work productivity [ Time Frame: 3 months post-inclusion ]
    To determine the superiority of Sunrise vs PSG on work productivity at 3 months post-inclusion using WPAI:SHP

  4. cost (€)/QALY [ Time Frame: 3 months post-diagnosis ]
    cost (€)/QALY gained 3 months post-diagnosis

  5. Net profit for the French social security [ Time Frame: estimated at 3 years ]
    Estimation of the net profit for the French social security at 3 years

  6. Comparison of CPAP compliance data [ Time Frame: 3 month after treatment initiation ]
    To determine the non-inferiority of Sunrise vs PSG on CPAP compliance measured at 3 months post-treatment by comparing CPAP average usage in both groups

  7. Comparison of Sunrise versus PSG diagnosis [ Time Frame: Up to 12 months ]
    To confirm the diagnosis performance of Sunrise compared to PSG by comparing the obstructive respiratory disturbance index (ORDI) in both groups

  8. Difference in the obstructive respiratory disturbance index (ORDI) [ Time Frame: Up to 12 months ]
    To measure the variability of the ORDI by comparing the 3 obstructive respiratory disturbance index (ORDI) measures provided by the Sunrise device (used 3 nights)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Man or woman aged between 18 to 80 years old
  • Patient referred for a suspicion of OSA
  • Patient having a smartphone and internet connection at home and able to use a mobile application
  • Patient affiliated to the social security system

Main exclusion criteria:

  • Patient with a previous sleep test performed within 5 years of inclusion
  • Patient previously treated for OSA within 5 years of inclusion
  • Patient suffering from severe chronic obstructive or restrictive pulmonary disease with or without oxygen at the discretion of the investigator
  • Patient refusing to shave his beard that could prevent him to wear the device on the chin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05057975


Contacts
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Contact: Jean-Louis PEPIN, Pr +33 4 76 76 87 66 JPepin@chu-grenoble.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49933
Contact: Frédéric GAGNADOUX, Pr    +33 2 41 35 36 95    frgagnadoux@chu-angers.fr   
Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP), Not yet recruiting
Bobigny,, France, 93000
Contact: Carole PLANES, Pr    +33 1 48 95 56 37    carole.planes@aphp.fr   
Nouvelle clinique Bel-Air Not yet recruiting
Bordeaux, France, 33073
Contact: Vincent PUEL, Dr    +33 5 57 81 05 87    vpuel001@gmail.com   
CHU Bordeaux - Hôpital Pellegrin Not yet recruiting
Bordeaux, France, 33076
Contact: Pierre PHILIP, Pr    +33 5 57 82 01 73    pierre.philip@chu-bordeaux.fr   
AP-HP Hôpital Henri Mondor Not yet recruiting
Créteil, France, 94000
Contact: Laurent BOYER, dr    +33 1 49 81 26 77    laurent.boyer@aphp.fr   
Chu Grenoble Alpes, Recruiting
Grenoble, France, 38043
Contact: Jean-Louis PEPIN, Pr    +33 4 76 76 87 66    JPepin@chu-grenoble.fr   
CHRU Lille - Hôpital Roger Salengro Not yet recruiting
Lille, France, 59037
Contact: Christelle CHARLEY MONACA, Pr    +33 3 20 44 63 62    Christelle.MONACA@CHRU-LILLE.FR   
Hôpital privé la Louvière Not yet recruiting
Lille, France, 59800
Contact: Thibaut GENTINA, Dr    +33 3 20 55 02 50    docteur.gentina@gmail.com   
CHU Lyon - Hôpital de la Croix-Rousse Not yet recruiting
Lyon, France, 69004
Contact: Laure PETER- DEREX, Dr    +33 4 72 07 17 69    laure.peter-derex@chu-lyon.fr   
Hôpital Européen Marseille Not yet recruiting
Marseille, France, 13003
Contact: Herve PEGLIASCO, dr    +33 4 13 42 72 40    H.PEGLIASCO@hopital-europeen.fr   
CHU Montpellier - Hôpital Gui-de-Chauliac Not yet recruiting
Montpellier, France, 34295
Contact: Yves DAUVILLIERS, Pr    +33 4 67 33 63 61    y-dauvilliers@chu-montpellier.fr   
AP-HP Hôpital Bichat-Claude Bernard Not yet recruiting
Paris, France, 75018
Contact: Marie Pia D'ORTHO, Pr    +33 1 40 25 84 01    marie-pia.dortho@bch.aphp.fr   
AP-HP CUP Hôpital Hôtel Dieu Not yet recruiting
Paris, France, 75181
Contact: Damien LÉGER, Pr    +33 1 42 34 85 63    damien.leger@aphp.fr   
Polyclinique Saint-Laurent Not yet recruiting
Rennes, France, 35700
Contact: Arnaud PRIGENT, dr    +33 2 99 25 65 35    dr.arnaudprigent@gmail.com   
Sponsors and Collaborators
Sunrise
ICUREsearch
Investigators
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Principal Investigator: Jean-Louis PEPIN, Pr CHU Grenoble Alpes
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Responsible Party: Sunrise
ClinicalTrials.gov Identifier: NCT05057975    
Other Study ID Numbers: PRO-545
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunrise:
polysomnography
obstructive sleep apnea
home sleep test
artificial intelligence
mandibular movement
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases