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Obstructive Sleep ApneaSUNSASNCT05057975

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

A study testing Sunrise and polysomnography in people with Obstructive Sleep Apnea, run by Sunrise at 19 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Sunrise and polysomnography
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
848 participants
Where
19 sitesFrance
Study dates
28 Oct 2021to 7 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • CHU Angers

    Angers, 49933

  • Hôpitaux Universitaires de Paris Seine Saint-Denis (HUPSSD, AP-HP),

    Bobigny, 93000

  • Nouvelle clinique Bel-Air

    Bordeaux, 33073

  • CHU Bordeaux - Hôpital Pellegrin

    Bordeaux, 33076

  • AP-HP Hôpital Henri Mondor

    Créteil, 94000

  • Chu Grenoble Alpes,

    Grenoble, 38043

  • CHRU Lille - Hôpital Roger Salengro

    Lille, 59037

  • Hôpital privé la Louvière

    Lille, 59800

  • CHU Lyon - Hôpital de la Croix-Rousse

    Lyon, 69004

  • Hôpital Européen Marseille

    Marseille, 13003

  • CHU Montpellier - Hôpital Gui-de-Chauliac

    Montpellier, 34295

  • CHRU de Nancy - Hôpital d'Adultes de Brabois

    Nancy, 54500

  • AP-HP Pitié Salpêtrière

    Paris, 75013

  • AP-HP Hôpital Bichat-Claude Bernard

    Paris, 75018

  • AP-HP CUP Hôpital Hôtel Dieu

    Paris, 75181

  • CHU de Reims - Hôpital Maison Blanche

    Reims, 51092

  • Polyclinique Saint-Laurent

    Rennes, 35700

  • Centre du Sommeil de Grenoble

    Saint-Martin-d'Hères, 38400

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31059

Other trials in France

About this study

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

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.

Read the 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 19 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.

Being tested
Sunrise, polysomnography
Keywords
polysomnography, obstructive sleep apnea, home sleep test, artificial intelligence, mandibular movement
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunriseDevice

    Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.

  • polysomnographyDevice

    Reference protocol to diagnose OSA (in-lab or outpatient PSG)

Study groups in NCT05057975
Study groupRoleWhat they receive
SunriseExperimentalHome Sleep Test, OSA diagnosis based on mandibular movements recording
Receives: Device: Sunrise
PSGActive comparatorPolysomnography, OSA diagnosis based on local scoring by center
Receives: Device: polysomnography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in daily sleepiness

    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.

    Measured: 3 months post-diagnosis

  2. Time to diagnosis

    To determine the superiority of Sunrise vs PSG in terms of time between inclusion and diagnosis appointment

    Measured: Up to 12 months

  3. Time to treatment

    To determine the superiority of Sunrise vs PSG in terms of time between inclusion and treatment initiation

    Measured: Up to 15 months

  4. Change in daily sleepiness

    To determine the superiority of Sunrise vs PSG on sleepiness at 3 months post-inclusion using ESS

    Measured: 3 months post inclusion

Secondary outcomes (8)

  1. Change in quality of life

    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.

    Measured: 3 months post inclusion visit

  2. Change in quality of life

    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.

    Measured: 3 months post inclusion visit

  3. Change in work productivity

    To determine the superiority of Sunrise vs PSG on work productivity at 3 months post-inclusion using WPAI:SHP

    Measured: 3 months post-inclusion

  4. cost (€)/QALY

    cost (€)/QALY gained 3 months post-diagnosis

    Measured: 3 months post-diagnosis

  5. Net profit for the French social security

    Estimation of the net profit for the French social security at 3 years

    Measured: estimated at 3 years

  6. Comparison of CPAP compliance data

    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

    Measured: 3 month after treatment initiation

  7. Comparison of Sunrise versus PSG diagnosis

    To confirm the diagnosis performance of Sunrise compared to PSG by comparing the obstructive respiratory disturbance index (ORDI) in both groups

    Measured: Up to 12 months

  8. Difference in the obstructive respiratory disturbance index (ORDI)

    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)

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start28 Oct 2021
  3. Primary completion7 Oct 2024
  4. Study completion7 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, controlled, randomized, parrallel, open label, multicenter and national
Masking
None (open label)
Enrolment
848 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05057975
Sponsor's protocol ID
PRO-545
Acronym
SUNSAS
Status last verified
Dec 2024
First submitted
27 Aug 2021
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sunrise and polysomnography in people with Obstructive Sleep Apnea, run by Sunrise at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in daily sleepiness (time frame: 3 months post-diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05057975.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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