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Portable Sleep Monitor

Portable Sleep Monitor for Obstructive Sleep Apnea

N/A
Waitlist Available
Led By Murray Krahn, MSc, MD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-5 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Obstructive Sleep Apnea

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the accuracy of the clinical diagnosis of OSA
To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with ApneaDx™ and the in-laboratory sleep study with polysomnography (PSG)
Secondary study objectives
To evaluate the cost-effectiveness (cost per quality-adjusted life year) of the OSA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Portable Sleep MonitorActive Control1 Intervention
The clinical diagnosis of OSA will be done according to the American Academy of Sleep Medicine criteria, a combination of data from clinical examination, presenting symptoms, risk factors and results from portable monitor sleep studies.
Group II: PolysomnographyActive Control1 Intervention
The clinical diagnosis of OSA will be done according to the American Academy of Sleep Medicine criteria, a combination of data from clinical examination, presenting symptoms, risk factors and results from polysomnography from the sleep clinic.

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Who is running the clinical trial?

University of TorontoLead Sponsor
714 Previous Clinical Trials
1,022,572 Total Patients Enrolled
Mars, Inc.Industry Sponsor
19 Previous Clinical Trials
26,274 Total Patients Enrolled
Murray Krahn, MSc, MDPrincipal InvestigatorUniversity of Toronto
~21 spots leftby Nov 2025
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