NCT02003729

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

December 2, 2013

Last Update Submit

June 1, 2015

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apneaPortable MonitorAHIESSCost effectiveness

Outcome Measures

Primary Outcomes (2)

  • To evaluate the accuracy of the clinical diagnosis of OSA

    • To evaluate the accuracy of the clinical diagnosis of OSA assisted by the home sleep study with ApneaDx against the clinical diagnosis assisted by the in-laboratory sleep study, PSG as the reference standard.

    4-5 months

  • 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)

    • To evaluate the agreement between the AHI from the home sleep study with ApneaDx™ and the in-laboratory sleep study with PSG in patients being referred to sleep clinics with suggestive OSA symptoms.

    5 months

Secondary Outcomes (1)

  • To evaluate the cost-effectiveness (cost per quality-adjusted life year) of the OSA

    4-5 months

Study Arms (2)

Portable Sleep Monitor

ACTIVE COMPARATOR

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.

Device: Portable Sleep Monitor

Polysomnography

NO 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.

Interventions

Portable Sleep MonitorDEVICE

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.

Also known as: ApneaDx
Portable Sleep Monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referral to a sleep clinic by a general practitioner or family physician with symptoms suggestive of OSA.
  • Provide signed informed consent
  • At least 18 years of age
  • Ability to complete study questionnaires either on their own or with assistance

You may not qualify if:

  • An existing diagnosis of other sleep disorders (eg, periodic limb movement disorder);
  • A history of neuromuscular diseases (e.g., multiple sclerosis, muscular dystrophy)
  • A history of congestive heart failure
  • A history of stroke/Transient Ischemic Attack
  • a history of chronic respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease, lung cancer, cystic fibrosis and occupational lung diseases)
  • Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Disorders Laboratory, Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Related Publications (1)

  • Fitzpatrick M, Rac VE, Mitsakakis N, Abrahamyan L, Pechlivanoglou P, Chung S, Carcone SM, Pham B, Kendzerska T, Zwarenstein M, Gottschalk R, George C, Kashgari A, Krahn M. SIESTA - Home sleep study with BresoDx for obstructive sleep apnea: a randomized controlled trial. Sleep Med. 2020 Jan;65:45-53. doi: 10.1016/j.sleep.2019.07.013. Epub 2019 Jul 22.

    PMID: 31707288DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Murray Krahn, MSc, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Murray Krahn, MD, MSc

CONTACT

416-978-6608murray.krahn@theta.utoronto.ca

Valeria Rac, MD, PhD

CONTACT

416-946-3706valeria.rac@theta.utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 6, 2013

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

CA(1)