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| Name | Class |
|---|---|
| University Hospital, Strasbourg, France | OTHER |
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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).
Secondary objectives
To assess the correlation of the following parameters:
To study the correlation between AHI measured by the Sunrise® medical device and desaturation index measured by ventilatory polygraphy.
Conduct of research
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected OSAHS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUNRISE© device | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Dorsal AHI | Day 1 | |
| Non- dorsal AHI | Day 1 | |
| Dorsal Obstructive respiratory disturbance index (ORDI) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | Bas-Rhin | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42168007 | Result | 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. |
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| Day 1 |
| Non dorsal ORDI | Day 1 |