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SIESTA: Home Sleep Study With ApneaDx™ for the Diagnosis of Obstructive Sleep Apnea

NCT02003729 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-06-03

No results posted yet for this study

Summary

The SIESTA Home Sleep Study is a pragmatic, multi-centre randomized single-blinded two arm trial, assisted by a Decision Analytic Model, primarily designed to assess the accuracy, effectiveness and cost-effectiveness of diagnosing OSA assisted by ApneaDx™ as compared to PSG as a reference standard.

Conditions

Interventions

DEVICE

Portable Sleep Monitor

ApneaDx™ is a new PM that uses a microphone to record breath sounds and an acoustical analysis algorithm of breath sounds to determine the AHI.

Sponsors & Collaborators

  • Mars, Inc.

    collaborator INDUSTRY

  • University of Toronto

    lead OTHER

Principal Investigators

  • Murray Krahn, MSc, MD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02003729 on ClinicalTrials.gov