NCT04926077

DreamKit Respiratory Effort Signal Validation

Validation of the DreamKit Plethysmography-derived Respiratory Effort Signal Against Esophageal Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (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 DreamKit respiratory effort signal.

Detailed description

The rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from DreamKit vs. the gold-standard esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device 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	DreamKit	The DreamKit 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: 2021-06-22
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2021-06-14
• Last updated: 2022-11-30
• Results posted: 2022-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study