Recruiting

ApneaDx™

Sponsor:

University of Toronto

Code:

NCT02003729

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Portable Sleep Monitor

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT02003729

Start date

Mar, 2014

Status verified date

Jun, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • To evaluate the accuracy of the clinical diagnosis of OSA [ Time Frame: 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) [ Time Frame: 5 months ]

Central Contacts and Locations

Central contacts

Murray Krahn, MD, MSc

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

Valeria Rac, MD, PhD

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

Locations

Sleep Disorders Laboratory, Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Mike Fitzpatrick, MD, MSc

613-545-2479mike.fitzpatrick@queensu.ca

Principal Investigator:

Murray Krahn, MD, MSc

More Information

Sponsor

University of Toronto

Last update posted

Jun 3, 2015

Last verified

Jun, 2015

Keywords

  • obstructive sleep apnea
  • Portable Monitor
  • AHI
  • ESS
  • Cost effectiveness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2015-06-03.