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Sparkle Respiratory Effort Validation

NCT04630639 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-06-23

No results posted yet for this study

Summary

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

Conditions

  • Sleep Apnea, Obstructive
  • Sleep Apnea, Central

Interventions

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.

Sponsors & Collaborators

  • Pulmonary Critical Care Associates of Baltimore

    collaborator OTHER

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • Alan Schwartz, MD · Pulmonary and Critical Care Associates of Baltimore

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630639 on ClinicalTrials.gov