Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460441
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
Comparison of the SUNRISE Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome Collection of Preliminary Data
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study Overview
Official Title:
Comparison of the SUNRISE Device With Ventilatory Polygraphy for the Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome Collection of Preliminary Data
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUNPV
Brief Summary:
Additional data on screening for obstructive sleep apneahypopnea 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
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
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 centers 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 patients 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
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 centers 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None