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

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).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Hypopnea Syndrome
• Intervention / Treatment: Diagnostic test: SUNRISE© device

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.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France
      • Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Suspected OSAHS

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Dorsal AHI	Day 1
Non- dorsal AHI	Day 1
Dorsal Obstructive respiratory disturbance index (ORDI)	Day 1
Non dorsal ORDI	Day 1

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Respiratory Tract Diseases; Disease; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Syndrome; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: GHRMSA 1350

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No