NCT04671342

DreamKit Diagnostic Validation

Diagnostic Validation of the DreamKit Device Against Polysomnography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (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 diagnostic efficacy of the DreamKit device against polysomnography.

Detailed description

The primary objective of this study is to assess the diagnostic performance of the DreamKit device against the gold-standard comparator, polysomnography (PSG). Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and in-laboratory PSG.

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.

Timeline

• Start date: 2021-01-14
• Primary completion: 2021-12-18
• Completion: 2021-12-18
• First posted: 2020-12-17
• Last updated: 2023-01-31
• Results posted: 2023-01-31

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study