Ignite Creation Date:
2025-12-18 @ 8:25 AM
Ignite Modification Date:
2025-12-23 @ 5:48 PM
Study NCT ID:
NCT05554315
Status:
None
Last Update Posted:
2025-09-22 00:00:00
First Post:
2022-09-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Speckle Plethysmography Pulse Transit Time as a Marker of Blood Pressure Changes
Sponsor:
None
Organization:
Study Overview
Official Title:
Speckle Plethysmography Pulse Transit Time as a Marker of Blood Pressure Changes
Status:
None
Status Verified Date:
2025-08-28
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:
Study Description:
This pilot study will investigate the use of a recently introduced optical technique, speckle plethysmography (SPG), as an alternative to photoplethysmography (PPG) for cuff-free blood pressure (BP) estimation using pulse transit time (PTT). Because of the increased signal quality of SPG in comparison to PPG, we hypothesize that pulse transit times calculated from ECG-SPG (sPTT) will have a better correlation to blood pressure than ECG-PPG (pPTT).
Objectives:
Primary Objective:
To examine the use of sPTT as a marker for blood pressure.
Secondary Objective:
To evaluate the use of sPTT in comparison to pPTT.
Exploratory Objectives:
1. To explore if the SPG waveform by itself can be used as a marker for blood pressure.
2. To evaluate signal quality of SPG in comparison to PPG across various skin tones.
Endpoints:
Primary Endpoints:
Pearson correlation coefficient between sPTT and BP.
Secondary Endpoints:
Pearson correlation coefficient between pPTT and BP.
Exploratory Endpoints:
1. Pearson correlation coefficient between BP and signal markers to be determined.
2. PPG Signal-to-noise ratio (SNR), SPG SNR
This pilot study will investigate the use of a recently introduced optical technique, speckle plethysmography (SPG), as an alternative to photoplethysmography (PPG) for cuff-free blood pressure (BP) estimation using pulse transit time (PTT). Because of the increased signal quality of SPG in comparison to PPG, we hypothesize that pulse transit times calculated from ECG-SPG (sPTT) will have a better correlation to blood pressure than ECG-PPG (pPTT).
Objectives:
Primary Objective:
To examine the use of sPTT as a marker for blood pressure.
Secondary Objective:
To evaluate the use of sPTT in comparison to pPTT.
Exploratory Objectives:
1. To explore if the SPG waveform by itself can be used as a marker for blood pressure.
2. To evaluate signal quality of SPG in comparison to PPG across various skin tones.
Endpoints:
Primary Endpoints:
Pearson correlation coefficient between sPTT and BP.
Secondary Endpoints:
Pearson correlation coefficient between pPTT and BP.
Exploratory Endpoints:
1. Pearson correlation coefficient between BP and signal markers to be determined.
2. PPG Signal-to-noise ratio (SNR), SPG SNR
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?: