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

NCT06460441 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2025-04-30

No results posted yet for this 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).

Conditions

  • Obstructive Sleep Apnea Hypopnea Syndrome

Interventions

DIAGNOSTIC_TEST

SUNRISE© 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.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    collaborator OTHER

  • Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06460441 on ClinicalTrials.gov