NCT04630639

Sparkle Respiratory Effort Validation

Validation of the Sparkle Respiratory Effort Signal Against Esophageal Pressure in Healthy Participants

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study has been developed in order to demonstrate the validity of the Sparkle respiratory effort signal.

Detailed description

The rationale for undertaking this study is to demonstrate that the agreement between the Sparkle respiratory effort signal amplitude and esophageal manometry is non-inferior to the agreement between the thoracic belt respiratory effort signal amplitude and esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the Sparkle device, respiratory belts, and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.

Conditions

• Sleep Apnea, Obstructive
• Sleep Apnea, Central

Interventions

Type	Name	Description
DEVICE	Sparkle	The Sparkle device is a single-use device intended to aid the diagnosis of sleep-disordered breathing; however, this study is intended only to validate the respiratory effort signal and does not assess diagnostic performance.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2020-11-16
• Last updated: 2021-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study