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

Obstructive Sleep Apnea Hypopnea Syndrome Clinical Trial

— SUNPV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460441
• Other study ID #: GHRMSA 1350
• Status: Not yet recruiting
• Start date: June 17, 2024
• Est. completion date: December 17, 2024

Study information

• Verified date: June 2024
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 17, 2024
• Est. primary completion date: December 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Hypopnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace	University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dorsal AHI		Day 1
Secondary	Non- dorsal AHI		Day 1
Secondary	Dorsal Obstructive respiratory disturbance index (ORDI)		Day 1
Secondary	Non dorsal ORDI		Day 1