Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04252482
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2020-01-30
Brief Title:
Validation of Sleep Healthcare System
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Validation of Sleep Healthcare System
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
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 smart watches which often measure wrist photoplethysmography PPG signal and body movement 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 AHI15hr 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 online system Good Sleep for diagnosis of sleep disorder has been set up under the collaboration between NTU NTUH and MediaTek It aims on population with low probability of sleep disorder which compliments the NTUH cohort high probability of sleep disorder The online system provides the diagnosis and solution of sleep disorder sleep tracking and education via both website and App The system is almost set and needs the input from general population to validate the accuracy
The sleep healthcare system which includes questionnaires smart watches24-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 filling out the questionnaire The aims of the present project include 1 All 300 voluntaryStage1 Recruit 140 voluntary participants from MediaTek to validate agreement of sleep efficiency via online system actigraph devices smart watches and daily blood pressure for one weekStage2 Recruit 160 voluntary participants from patients with moderate-severe OSA AHI15hr to validate agreement of sleep efficiency via online system actigraph devices smart watches ECG Holter and 24 hour blood pressure for one day 2 All participants will take an overnight PSG test blood sampling basal metabolism measurement ECG Holter body composition and E-Prime at the sleep center to validate the performance of online 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 AHI15hr 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 online system Good Sleep for diagnosis of sleep disorder has been set up under the collaboration between NTU NTUH and MediaTek It aims on population with low probability of sleep disorder which compliments the NTUH cohort high probability of sleep disorder The online system provides the diagnosis and solution of sleep disorder sleep tracking and education via both website and App The system is almost set and needs the input from general population to validate the accuracy
The sleep healthcare system which includes questionnaires smart watches24-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 filling out the questionnaire The aims of the present project include 1 All 300 voluntaryStage1 Recruit 140 voluntary participants from MediaTek to validate agreement of sleep efficiency via online system actigraph devices smart watches and daily blood pressure for one weekStage2 Recruit 160 voluntary participants from patients with moderate-severe OSA AHI15hr to validate agreement of sleep efficiency via online system actigraph devices smart watches ECG Holter and 24 hour blood pressure for one day 2 All participants will take an overnight PSG test blood sampling basal metabolism measurement ECG Holter body composition and E-Prime at the sleep center to validate the performance of online 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