Ignite Creation Date:
2025-12-18 @ 9:48 AM
Ignite Modification Date:
2025-12-23 @ 5:47 PM
Study NCT ID:
NCT07095413
Status:
None
Last Update Posted:
2025-07-31 00:00:00
First Post:
2025-07-14 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea
Sponsor:
None
Organization:
Study Overview
Official Title:
Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea Diagnosis in Adult Populations
Status:
None
Status Verified Date:
2025-07
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:
None
Brief Summary:
This study aims to validate the Wesper Lab wireless sensors as a reliable alternative to traditional PSG for diagnosing sleep apnea, potentially providing a more convenient method for patients while maintaining diagnostic accuracy. The structured approach to data collection, monitoring, and follow-up underscores a thorough methodology to assess both effectiveness and safety. The study is a single-center, single-arm clinical trial designed to evaluate the effectiveness of the Wesper Lab wireless sensors for aiding in the diagnosis of sleep apnea, specifically comparing its performance to overnight polysomnography (PSG).
The primary aim is to determine how well the Wesper Lab wireless sensors correlate with traditional PSG results in measuring obstructive sleep apnea (OSA) and central sleep apnea (CSA) through key metrics, specifically the apnea-hypopnea index (AHI) and central apnea/hypopnea index (CAHI).
Approximately 100 eligible adult patients (≥21 years) who have been referred by a physician for an overnight PSG test to evaluate sleep apnea.
Patients will undergo PSG testing while simultaneously wearing two Wesper Lab sensors and a compatible pulse oximeter for one night at the clinic. Sleep technicians will monitor and set up the devices, and data will be collected via a smartphone app linked to the Wesper Lab system. The PSG will record brain activity, blood oxygen levels, heart rate, breathing patterns, and movements. Data will be collected during the sleep period, and post-study, the signals will be analyzed by qualified readers who are blinded to the device used for data collection.
To demonstrate that the correlation between the AHI/CAHI from the Wesper Lab and PSG exceeds a predefined performance goal (PG) using Pearson correlation. To establish that the 95% limits of agreement between AHI/CAI from the two devices fall within acceptable upper and lower limits. Evaluate inter-rater reliability of AHI/CAHI readings. Assess agreement in apnea classification (mild, moderate, severe) between the two methods.
Analyze differences based on sleep position (supine vs. non-supine).
The primary safety endpoints include tracking adverse events (AEs) and serious adverse events (SAEs) related to the use of the Wesper Lab device throughout the study.
The primary aim is to determine how well the Wesper Lab wireless sensors correlate with traditional PSG results in measuring obstructive sleep apnea (OSA) and central sleep apnea (CSA) through key metrics, specifically the apnea-hypopnea index (AHI) and central apnea/hypopnea index (CAHI).
Approximately 100 eligible adult patients (≥21 years) who have been referred by a physician for an overnight PSG test to evaluate sleep apnea.
Patients will undergo PSG testing while simultaneously wearing two Wesper Lab sensors and a compatible pulse oximeter for one night at the clinic. Sleep technicians will monitor and set up the devices, and data will be collected via a smartphone app linked to the Wesper Lab system. The PSG will record brain activity, blood oxygen levels, heart rate, breathing patterns, and movements. Data will be collected during the sleep period, and post-study, the signals will be analyzed by qualified readers who are blinded to the device used for data collection.
To demonstrate that the correlation between the AHI/CAHI from the Wesper Lab and PSG exceeds a predefined performance goal (PG) using Pearson correlation. To establish that the 95% limits of agreement between AHI/CAI from the two devices fall within acceptable upper and lower limits. Evaluate inter-rater reliability of AHI/CAHI readings. Assess agreement in apnea classification (mild, moderate, severe) between the two methods.
Analyze differences based on sleep position (supine vs. non-supine).
The primary safety endpoints include tracking adverse events (AEs) and serious adverse events (SAEs) related to the use of the Wesper Lab device throughout the study.
Detailed Description:
None
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?: