CompletedNot Applicable

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

France37 participantsStarted 2024-06-19

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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: * 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.

What they're measuring

Apnea-hypopnea index (AHI)

Timeframe: Day 1

Trial details

NCT IDNCT06460441

SponsorGroupe Hospitalier de la Region de Mulhouse et Sud Alsace

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-28