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

NCT06460441 | Completed

• 1 other identifier: GHRMSA 1350
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  Day 1

Secondary Outcomes (4)

• Dorsal AHI

  Day 1

• Non- dorsal AHI

  Day 1

• Dorsal Obstructive respiratory disturbance index (ORDI)

  Day 1

• Non dorsal ORDI

  Day 1

Study Arms (1)

Suspected OSAHS

Diagnostic Test: SUNRISE© device

Interventions

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.

Suspected OSAHS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead
• University Hospital, Strasbourg, France: collaborator

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 19, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)