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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of Toronto
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
Murray Krahn, University of Toronto
ClinicalTrials.gov Identifier:
NCT02003729
First received: December 2, 2013
Last updated: June 1, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: Portable Sleep Monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: SIESTA: Home Sleep Study With ApneaDx™ for the Diagnosis of Obstructive Sleep Apnea: A Pragmatic Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • To evaluate the accuracy of the clinical diagnosis of OSA [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
    • 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.

  • 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) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    • 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.


Secondary Outcome Measures:
  • To evaluate the cost-effectiveness (cost per quality-adjusted life year) of the OSA [ Time Frame: 4-5 months ] [ Designated as safety issue: No ]
    • To evaluate the cost-effectiveness (cost per quality-adjusted life year) of the OSA after diagnosis based on home sleep study with ApneaDx™ in comparison with after diagnosis based on an in-laboratory sleep study with PSG.


Estimated Enrollment: 250
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Portable Sleep Monitor
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
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.
Other Name: ApneaDx
No Intervention: Polysomnography
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.

Detailed Description:

In Ontario, approximately 130,000 sleep studies were conducted in 2008, which is twice the number of sleep studies reported in 1999. In 2008, Ontario spent approximately $40 million on polysomnography (PSG) testing alone, despite the fact that access to PSG remained limited, with an average waiting time of approximately 3.5 months for an in-laboratory sleep study and approximately 12 months from referral to appropriate treatment. Portable monitors (PM) have been developed in an effort to substitute for the more costly and labor intensive clinic-based PSG. As of 2011, there are over 40 PM commercially available in the United States with different configurations for cardiorespiratory and neurophysiologic signals.

At the request of the Ontario Health Technology Advisory Committee (OHTAC), a panel that makes recommendations to the Ontario Ministry of Health and Long-Term Care about the uptake and diffusion of health technologies, the Toronto Rehabilitation Institute convened an expert panel in 2007 to explore alternative approaches to the diagnosis of obstructive sleep apnea (OSA). Members of the expert panel suggested that despite the availability of a large number of PMs, home assessments are problematic as technicians are required to ensure continuous placement of electrodes for reliable testing. They also suggested that a good screening tool was not available at that time. The Toronto Rehabilitation Institute therefore undertook a research study that eventually led to the development of the ApneaDx™ PM.

ApneaDx™ is a new PM that uses a microphone to record breath sounds and an acoustical analysis algorithm of breath sounds to determine the (Apnea Hypopnea Index) AHI. Results from preliminary studies suggest that the AHI derived from ApneaDx™ approximates that from PSG. In preliminary studies, it appears that for the diagnosis of sleep apnea, home sleep study with ApneaDx™ is simple and reliable even when conducted by untrained users.

This study evaluates the effectiveness and cost-effectiveness of OSA diagnosed assisted by a home sleep study with ApneaDx™. This study will be conducted by the Toronto Health Economics and Technology Assessment (THETA) Collaborative. Data from this study will be used to support practice recommendations regarding the use of a home sleep study with ApneaDx™ as input for diagnosis of OSA by the OHTAC and reimbursement considerations by the Ontario Ministry of Health and Long-Term Care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003729

Contacts
Contact: Murray Krahn, MD, MSc 416-978-6608 murray.krahn@theta.utoronto.ca
Contact: Valeria Rac, MD, PhD 416-946-3706 valeria.rac@theta.utoronto.ca

Locations
Canada, Ontario
Sleep Disorders Laboratory, Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Mike Fitzpatrick, MD, MSc    613-545-2479    mike.fitzpatrick@queensu.ca   
Principal Investigator: Murray Krahn, MD, MSc         
Sponsors and Collaborators
University of Toronto
Mars, Inc.
Investigators
Principal Investigator: Murray Krahn, MSc, MD University of Toronto
  More Information

No publications provided

Responsible Party: Murray Krahn, MD, MSc, University of Toronto
ClinicalTrials.gov Identifier: NCT02003729     History of Changes
Other Study ID Numbers: 29539
Study First Received: December 2, 2013
Last Updated: June 1, 2015
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by University of Toronto:
obstructive sleep apnea
Portable Monitor
AHI
ESS
Cost effectiveness

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders
Sleep Disorders, Intrinsic
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on July 01, 2015