Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, France
NCT Number: NCT06460441
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Strasbourg, Bas-Rhin, France
Secondary objectives
Conduct of research
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1
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.
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Other
Acronym: SUNPV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03845062
Obstructive Sleep Apnea Hypopnea Syndrome
Montpellier, France
View Trial DetailsNCT03817762
Obstructive Sleep Apnea Hypopnea Syndrome
Montpellier, France
View Trial Details