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CompletedNCT06460441SUNPVUpdated May 29, 2026

Comparison of the SUNRISE© Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome: Collection of Preliminary Data

An observational study in Obstructive Sleep Apnea Hypopnea Syndrome, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
01

Study summary

Additional data on screening for obstructive sleep apnea/hypopnea syndrome (OSAHS) in patients with co-morbidities, such as diabetics and those with chronic respiratory diseases would enable current recommendations to evolve, with a view to promoting the widespread use of simplified techniques for OSAHS screening, particularly in patients with cardiorespiratory co-morbidities.

The primary objective of this observational multicentric pilot study is to compare the performance of the Sunrise® medical device with that of ventilatory polygraphy as part of routine screening for OSAHS in diabetic patients followed up in the diabetology department of the Strasbourg University Hospital, and in patients followed up in the pneumology consultation department of Mulhouse Hospital (GHRMSA).

Read the detailed description

Secondary objectives

  1. To assess the correlation of the following parameters:

    • dorsal Apnea-Hypopnea Index (AHI) measured by ventilatory polygraphy and dorsal Obstructive Respiratory Disturbance Index (ORDI) measured by Sunrise® device
    • non-dorsal AHI measured by ventilatory polygraphy and non-dorsal ORDI measured by Sunrise® device
  2. To study the correlation between AHI measured by the Sunrise® medical device and desaturation index measured by ventilatory polygraphy.

Conduct of research

  • At Strasbourg University Hospital, the study will be proposed to patients admitted for diabetic assessment who require ventilatory polygraphy.
  • At Mulhouse hospital (GHRMSA), patients are referred to a pneumologist in case of suspected OSAHS and a ventilatory polygraphy is scheduled at home. Patients scheduled to undergo this examination will be invited to take part in the study.

Ventilatory polygraphy (routine care):

Patients included in the study will receive an additional recording using the Sunrise© medical device, performed simultaneously with the ventilatory polygraphy.

Ventilatory polygraphy will be performed in accordance with each center's usual practices. For patients undergoing home polygraphy (GHRMSA), the care team will install the sensors and program the device for recording during sleep. The patient will return home and spend the night there, before coming back to the hospital the following day to give back the equipment. For patients hospitalized in the diabetology department of Strasbourg University Hospital, ventilatory polygraphy will be carried out during hospitalization.

Sunrise© medical device (examination added by research):

The mobile application will be installed on patient's smartphone by the study investigating team, and the use of the Sunrise© device will be explained to the patient. Recording will take place on the same night as the ventilatory polygraphy.

The day after recording, the Sunrise© sensor and ventilatory polygraph equipment will be collected by the investigating team.

02

Conditions studied

  • Obstructive Sleep Apnea Hypopnea Syndrome
03

In context

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will be proposed to diabetic patients treated in the diabetology department of the Strasbourg University Hospital, as well as to patients referred to the pneumology consultation at the GHRMSA (Mulhouse) who need to have their sleep disorders investigated using ventilatory polygraphy.

Inclusion criteria

  • Patient aged 18 or over;
  • Patient with a smartphone (Android or iOS) with Bluetooth and Internet connection and able to use the mobile application associated with the Sunrise© medical device;
  • Patient having a scheduled exploration by ventilatory polygraphy;
  • Non-opposition to participation in the research.

Exclusion criteria

Exclusion Criteria:

  • Patient suffering from a psychiatric pathology or with a history of behavioral disorders;
  • Patient already treated for OSAHS;
  • Patient refusing to cut his beard (if too abundant to wear the Sunrise© device);
  • Patient suffering from a pathology affecting the rotation of the condyle in the temporomandibular joint;
  • Patient deprived of liberty by judicial or administrative decision;
  • Patients under court protection or legal guardianship.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • Suspected OSAHS

    Diagnostic Test: SUNRISE© device

Interventions

  • Diagnostic testSUNRISE© device

    The device under study is the Sunrise© sensor, a single-use Class IIa medical device with CE marking and ISO 13485 certification. The system combines a mandibular movement sensor with an artificial intelligence program to collect and interpret data. It consists of a three-gram device that is placed on the chin using an adhesive. The sensor is linked to a (free) mobile app, enabling data to be sent to the Sunrise© company's secured platform at the end of the night, and results to be transmitted to the prescribing physician.

06

What researchers measure

Primary outcomes

  1. Apnea-hypopnea index (AHI)

    The apnea-hypopnea index (AHI) will be measured using the Sunrise® medical device and ventilatory polygraphy. It corresponds to the number of apnea-hypopnea episodes per hour of sleep.

    Time frame: Day 1

Secondary outcomes

  1. Dorsal AHI

    Time frame: Day 1

  2. Non- dorsal AHI

    Time frame: Day 1

  3. Dorsal Obstructive respiratory disturbance index (ORDI)

    Time frame: Day 1

  4. Non dorsal ORDI

    Time frame: Day 1

07

Study locations

1 site
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, Bas-Rhin, France
08

References and documents

Publications

  • Nassurally F, Palpacuer C, Leclercq A, Iamandi C, Renaud-Picard B, Fall-Mostaine F, Debieuvre D, Mohamed R, Meyer L, Kessler L, Kessler R. [Automated analysis of mandibular movements for the screening of obstructive sleep apnea]. Rev Mal Respir. 2026 May 21:S0761-8425(26)00028-8. doi: 10.1016/j.rmr.2026.05.001. Online ahead of print. French. PubMed 42168007 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06460441
Lead sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Collaborators
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Jun 19, 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
May 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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