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DreamKit Diagnostic Validation

NCT04671342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2023-01-31

Study results available
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Summary

This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.

Conditions

  • Sleep Apnea, Obstructive
  • Sleep Apnea, Central

Interventions

DEVICE

DreamKit

The DreamKit device is a single-use device intended to aid the diagnosis of sleep-disordered breathing.

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • Bill Hardy · Philips Sleep & Respiratory Care

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2021-12-18
Completion
2021-12-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04671342 on ClinicalTrials.gov