Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05928923
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2023-06-25
Brief Title:
The Screening and the Treatment of ECG Holter and Sleep Apnea
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
The Screening and the Treatment of ECG Holter and Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
Sleep quality affect working and learning performance poor quality of sleep is one of the common problems of modern people Traditionally polysomnography is a recognized standard for sleep quality assessment Subjects are put adhesive electrodes chest and abdomen band oximetery and oronasal cannula and stay in certified sleep laboratory for monitoring These sensors setup are cumbersome and be likely to induce discomfort An alternative to assess the quality of sleep is actigraphy which allows users to wear for more than two weeks In recent years many of the devices which often measure physiological signals are prevailing to make long-term sleep monitoring feasible but its accuracy and effectiveness still need to be verified
Obstructive sleep apnea OSA is a common disorder characterized by intermittent hypoxia and sleep fragmentation OSA is associated with cardiovascular morbidity and mortality metabolic dysregulation and neurocognitive dysfunction which results in the negative impact on prognosis PSG is the gold standard for OSA diagnosis which is expensive and less accessible Therefore modality other than PSG is necessary to speed up diagnosis and treatment Center of Sleep Disorder in National Taiwan University Hospital has been operated since June 2006 Up to Dec2015 totally 8819 patients have been referred for sleep studies NTUH cohort where 1435 patients are under long-term CPAP and 396 patients are under MAD Using data from 4618 patients in NTUH cohort we have already established an OSA prediction mode apnea-hypopnea index AHI5hr with accuracy 8237 sensitivity 8703 positive predictive value 91 Regarding the molecular mechanism our previous study showed that by plasma metabolomics profiling we could identify candidate metabolites associated with OSA severity The 11 candidate metabolites were identified by comparing profiling in 100 patients with AHI 15hr and with AHI 15hr respectively Six identified metabolites were selected to establish an AHI prediction model which gave sensitivity 66 specificity 72 and AUROC 0736 Furthermore 15 plasma metabolites associated with excessive daytime sleepiness EDS or polysomnographic parameters were identified Among those metabolites L-Kynurenine and g-Glutamylleucine were metabolites associated with EDS which generated the AUROC to EDS prediction as 63 in study group and 767 in validation group The LARGANECG Holter for diagnosis of sleep disorder has been set up by LARGAN-health It aims on population with simple diagnosis of sleep disorder Combining the LARGANECG Holter provides the diagnosis and solution of sleep disorder sleep tracking and education This devices is almost set and needs the input from general population to validate the accuracy
The trial which includes questionnaires Actigraph devices 24-hr BP and LARGANECG Holter for long-term home sleep monitoring is proposed to allow users to detect potential subjects who have sleep disorders by using the ECG Holter The aims of the present project include 1 All 190 voluntary Recruit 30 voluntary participants from patients with mild OSA AHI5-15hr 160 for each voluntary participants from patients with moderate OSA AHI15-30hr and severe OSA AHI30hr to validate agreement of sleep efficiency via this trial Actigraph devices and ECG Holter for 9 days and 24 hour blood pressure for one day 2 All participants will take an overnight PSG test blood sampling basal metabolism measurement Actigraph devices ECG Holter body composition and E-Prime at the sleep center to validate the performance of this system on diagnosis of OSA in low risk population 3 Analyze the of PSG parameters in both low and high risk population to build up the out of center devices for OSA home testing 4 Integrate the clinical parameters and plasma metabolic profile before and after treatment to identify factors associated with OSA related sequels and long-term prognosis
Obstructive sleep apnea OSA is a common disorder characterized by intermittent hypoxia and sleep fragmentation OSA is associated with cardiovascular morbidity and mortality metabolic dysregulation and neurocognitive dysfunction which results in the negative impact on prognosis PSG is the gold standard for OSA diagnosis which is expensive and less accessible Therefore modality other than PSG is necessary to speed up diagnosis and treatment Center of Sleep Disorder in National Taiwan University Hospital has been operated since June 2006 Up to Dec2015 totally 8819 patients have been referred for sleep studies NTUH cohort where 1435 patients are under long-term CPAP and 396 patients are under MAD Using data from 4618 patients in NTUH cohort we have already established an OSA prediction mode apnea-hypopnea index AHI5hr with accuracy 8237 sensitivity 8703 positive predictive value 91 Regarding the molecular mechanism our previous study showed that by plasma metabolomics profiling we could identify candidate metabolites associated with OSA severity The 11 candidate metabolites were identified by comparing profiling in 100 patients with AHI 15hr and with AHI 15hr respectively Six identified metabolites were selected to establish an AHI prediction model which gave sensitivity 66 specificity 72 and AUROC 0736 Furthermore 15 plasma metabolites associated with excessive daytime sleepiness EDS or polysomnographic parameters were identified Among those metabolites L-Kynurenine and g-Glutamylleucine were metabolites associated with EDS which generated the AUROC to EDS prediction as 63 in study group and 767 in validation group The LARGANECG Holter for diagnosis of sleep disorder has been set up by LARGAN-health It aims on population with simple diagnosis of sleep disorder Combining the LARGANECG Holter provides the diagnosis and solution of sleep disorder sleep tracking and education This devices is almost set and needs the input from general population to validate the accuracy
The trial which includes questionnaires Actigraph devices 24-hr BP and LARGANECG Holter for long-term home sleep monitoring is proposed to allow users to detect potential subjects who have sleep disorders by using the ECG Holter The aims of the present project include 1 All 190 voluntary Recruit 30 voluntary participants from patients with mild OSA AHI5-15hr 160 for each voluntary participants from patients with moderate OSA AHI15-30hr and severe OSA AHI30hr to validate agreement of sleep efficiency via this trial Actigraph devices and ECG Holter for 9 days and 24 hour blood pressure for one day 2 All participants will take an overnight PSG test blood sampling basal metabolism measurement Actigraph devices ECG Holter body composition and E-Prime at the sleep center to validate the performance of this system on diagnosis of OSA in low risk population 3 Analyze the of PSG parameters in both low and high risk population to build up the out of center devices for OSA home testing 4 Integrate the clinical parameters and plasma metabolic profile before and after treatment to identify factors associated with OSA related sequels and long-term prognosis
Detailed Description:
None
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