Trial record 5 of 4350 for:    sleep

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 19, 2014
Last verified: March 2014
  Purpose

The Home Sleep Study of ApneaDx is a pragmatic, multi-centre randomized double-blinded two arm non-inferiority trial primarily designed to assess the effectiveness and cost-effectiveness of management of obstructive sleep apnea (OSA)after diagnosis based on ApneaDx™ a portable monitor as compared to based on polysomnography (PSG) and to evaluate the agreement between home sleep study with Apnea Dx™ and in-laboratory sleep study with PSG in patients being referred to sleep clinics with suggestive OSA symptoms.


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 and Management 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:
  • Effectiveness of management of obstructive sleep apnea (OSA) after diagnosis [ Time Frame: 3 months post treatment ] [ Designated as safety issue: No ]
    We will assess the non-inferiority of management of obstructive sleep apnea (OSA) after diagnosis based upon home sleep study with ApneaDx™ (i.e., home sleep study versus in-laboratory sleep study) through changes from baseline in daytime sleepiness as measured by the total Epworth Sleepiness Score (ESS) at 3 months post treatment among all subjects.

  • 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 Apnea Hypopnea Index (AHI) levels obtained from the home sleep study with ApneaDx™ and the in-laboratory sleep study with polysomnography (PSG) the Bland-Altman plots will be used.


Secondary Outcome Measures:
  • • To evaluate the cost-effectiveness of the management of (obstructive sleep apnea) OSA after diagnosis based upon home sleep study in comparison with management of OSA after diagnosis based upon an in-laboratory sleep study [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    An economic evaluation alongside the (Randomized Controlled Trial) RCT will be undertaken as baseline. An alternative scenario where a decision analytic model will be used to project this economic evaluation in a lifetime horizon will also be conducted.

  • • To validate the diagnosis of OSA based on home sleep study with ApneaDx™ in comparison with in-laboratory sleep study with PSG [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    we will derive the following outcome measures: 1)Sensitivity (i.e., the proportion of subjects diagnosed with OSA according to the reference standard of in-laboratory sleep study with PSG, that are diagnosed with OSA based upon home sleep study with ApneaDx™), 2)Specificity (i.e., the proportion of subjects diagnosed without OSA according to the reference standard of in-laboratory sleep study with PSG, that are diagnosed without-OSA based upon home sleep study with ApneaDx™), 3)Positive and negative likelihood ratios

  • Quality of Life [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    At baseline and end of the study visits, the subjects will be requested to fill in the disease-specific Sleep Apnea Quality of Life Index questionnaire (SAQLI) and the health-related quality of life EuroQol EQ-5D™ questionnaire will be asked monthly by the site coordinator in follow up telephone calls.


Estimated Enrollment: 330
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
Trial subjects will be managed according to the diagnosis and treatment plan following their consultation with the sleep specialist. 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
Trial subjects will be managed according to the diagnosis and treatment plan following their consultation with the sleep specialist. 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 ApneaDxTM 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 management of OSA diagnosed based on 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 ApneaDxTM 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: March 19, 2014
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, Intrinsic
Sleep Disorders
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on August 27, 2014