Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06218186
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2024-01-11
Brief Title:
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
Sponsor:
Tatch Inc
Organization:
Tatch Inc
Study Overview
Official Title:
A Single Arm Quantitative Study Assessing Performance of Wesper Lab as a Tool to Aid in Sleep Apnea Diagnosis in Pediatric Populations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab previously known as TatchSleep Pro a wireless home sleep test as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography PSG evaluation in a pediatric population subjects 2 to 21 years of age
The main questions it aims to answer are
Does Wesper Lab demonstrate agreement with PSG for the calculation of the apneahypopnea index AHI
Does Wesper Lab demonstrate agreement with PFG for the calculation of sleep apnea severity
Participants that are already undergoing a prescribed PSG for the detection of sleep apnea will be asked to simultaneously wear the Wesper Lab sensors and an FDA approved pulse oximeter
Researchers will compare the AHI of Wesper Lab to the AHI of the PSG to determine the accuracy of the Wesper Lab device
This is a single center single-arm quantitative study
The main questions it aims to answer are
Does Wesper Lab demonstrate agreement with PSG for the calculation of the apneahypopnea index AHI
Does Wesper Lab demonstrate agreement with PFG for the calculation of sleep apnea severity
Participants that are already undergoing a prescribed PSG for the detection of sleep apnea will be asked to simultaneously wear the Wesper Lab sensors and an FDA approved pulse oximeter
Researchers will compare the AHI of Wesper Lab to the AHI of the PSG to determine the accuracy of the Wesper Lab device
This is a single center single-arm quantitative study
Detailed Description:
This is a single center single-arm quantitative study evaluating the effectiveness of the Wesper Lab previously known as TatchSleep Pro wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography PSG evaluation in a pediatric population
Investigators will identify approximately 150 eligible pediatric patients 50 subjects per subgroup who have been recommended to receive an overnight PSG for the detectionevaluation of sleep apnea Subgroups include pediatric patients in the following age ranges subgroup 1 2-5 years old subgroup 2 6-11 years old subgroup 3 12-21 years old
After informed consent is obtained a brief sleep-related medical history will be collected including relevant demographics Females of childbearing potential 12 years or older will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study
Patients will undergo their PSG test while simultaneously wearing 2 Wesper Lab patches and an FDA-cleared pulse oximeter compatible with and connected to the Wesper Lab system for a single night at the clinic The same make and model of pulse oximeter will be used for all subjects Patients will be observed overnight by trained sleep technicians who will setup the Wesper Lab device and collect the sleep data via the companion smartphone application
A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events
Following the data collection sleep data from PSG and Wesper Lab will be scored by an independent qualified sleep technologist the primary reader to yield an analysis of the accuracy of Wesper Lab compared with the PSG signals At least one and up to two additional readers secondary readers will score only the Wesper Lab data to obtain an estimate of inter-rater reliability
Accuracy of the Wesper Lab device will be demonstrated by comparing the Pearson correlation of Wesper Lab and PSG AHI to a performance goal The performance goal is based on a meta-analysis of FDA-cleared similar devices Fishers transformation and one-sided Z-test will be used to test the hypotheses with a significance level of 0025 The upper and lower 95 Bland-Altman limits of agreement will be calculated and statistically compared using a Wald test to performance goals based on a meta-analysis of FDA-cleared similar devices Deming regression will also be presented The inter-rater reliability of Wesper Lab AHIs will be calculated
Investigators will identify approximately 150 eligible pediatric patients 50 subjects per subgroup who have been recommended to receive an overnight PSG for the detectionevaluation of sleep apnea Subgroups include pediatric patients in the following age ranges subgroup 1 2-5 years old subgroup 2 6-11 years old subgroup 3 12-21 years old
After informed consent is obtained a brief sleep-related medical history will be collected including relevant demographics Females of childbearing potential 12 years or older will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study
Patients will undergo their PSG test while simultaneously wearing 2 Wesper Lab patches and an FDA-cleared pulse oximeter compatible with and connected to the Wesper Lab system for a single night at the clinic The same make and model of pulse oximeter will be used for all subjects Patients will be observed overnight by trained sleep technicians who will setup the Wesper Lab device and collect the sleep data via the companion smartphone application
A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events
Following the data collection sleep data from PSG and Wesper Lab will be scored by an independent qualified sleep technologist the primary reader to yield an analysis of the accuracy of Wesper Lab compared with the PSG signals At least one and up to two additional readers secondary readers will score only the Wesper Lab data to obtain an estimate of inter-rater reliability
Accuracy of the Wesper Lab device will be demonstrated by comparing the Pearson correlation of Wesper Lab and PSG AHI to a performance goal The performance goal is based on a meta-analysis of FDA-cleared similar devices Fishers transformation and one-sided Z-test will be used to test the hypotheses with a significance level of 0025 The upper and lower 95 Bland-Altman limits of agreement will be calculated and statistically compared using a Wald test to performance goals based on a meta-analysis of FDA-cleared similar devices Deming regression will also be presented The inter-rater reliability of Wesper Lab AHIs will be calculated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None