Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573372
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-24
Brief Title:
Evaluating the Diagnostic Efficacy of Smartwatch and Smartphone for Sleep Apnea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Validation Study on the Assessment of Sleep Apnea by Smart Watch and Smartphone
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening The study will be conducted in individuals suspected of having OSA Subjects will undergo gold standard PSG assessment overnight polysomnography with staff supervision in a sleep monitoring room while wearing a smartwatch and smartphone for monitoring The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA
Detailed Description:
OSA is common frequently-occurring disease in the general population prevalence of 9 to 382 in apnea hypoventilation index AHI 5 for the standard or higher A OSA according to the global burden of global nearly 1 billion patients with OSA and our country is the most populous country3 in the OSA sick on the basis of AHI 5 or more China has 176 million OSA crowd With AHI 15 as the standard China has 66 million people with OSA Although the high prevalence of OSA diagnostic rate was very low a study shows there are now about 90 of undiagnosed4 OSA The serious influence the diagnosis and treatment of OSA and downstream disease prevention and control
There are many reasons for the low diagnosis rate of OSA About the danger of OSA patients with insufficient understanding and OSA diagnosis treatment process link is the more important reason The OSA diagnosis depends on the patient to the hospital after outpatient service initiated or portable polysomnography evaluation limited by registered see a doctor make an appointment monitoring and many other processes as well as the level of understanding of OSA patients many patients with OSA dont want to come to the hospital With the popularity of intelligent wearable devices intelligent wearable device can effectively monitor the human multiple physiological indicators and has high comfort the cost is low the detection process is not restricted by time and place etc Besides smartphones by smart sensors collect the snoring heart shock signals BCG and respiratory physiological parameters such as non-contact multi-parameter sleep monitoring technology made possible by the These are the home sleep monitoring way to provide more convenient and easy to use makes the risk of OSA screening more convenient5-8
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening The study will be conducted in individuals suspected of having OSA Subjects will undergo gold standard PSG assessment overnight polysomnography with staff supervision in a sleep monitoring room while wearing a smartwatch and smartphone for monitoring The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA
There are many reasons for the low diagnosis rate of OSA About the danger of OSA patients with insufficient understanding and OSA diagnosis treatment process link is the more important reason The OSA diagnosis depends on the patient to the hospital after outpatient service initiated or portable polysomnography evaluation limited by registered see a doctor make an appointment monitoring and many other processes as well as the level of understanding of OSA patients many patients with OSA dont want to come to the hospital With the popularity of intelligent wearable devices intelligent wearable device can effectively monitor the human multiple physiological indicators and has high comfort the cost is low the detection process is not restricted by time and place etc Besides smartphones by smart sensors collect the snoring heart shock signals BCG and respiratory physiological parameters such as non-contact multi-parameter sleep monitoring technology made possible by the These are the home sleep monitoring way to provide more convenient and easy to use makes the risk of OSA screening more convenient5-8
The purpose of this study is to evaluate the diagnostic value of smartphones and watches for OSA screening The study will be conducted in individuals suspected of having OSA Subjects will undergo gold standard PSG assessment overnight polysomnography with staff supervision in a sleep monitoring room while wearing a smartwatch and smartphone for monitoring The results will be compared to evaluate the diagnostic value of smartwatches and smartphones for OSA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None