Obstructive Sleep ApneaNCT02003729
SIESTA: Home Sleep Study With ApneaDx™ for the Diagnosis of Obstructive Sleep Apnea
A study testing Portable Sleep Monitor in people with Obstructive Sleep Apnea, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Portable Sleep Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sleep Disorders Laboratory, Kingston General Hospital
Kingston, Ontario, K7L 2V7
Mike Fitzpatrick, MD, MSc, 613-545-2479, mike.fitzpatrick@queensu.ca
Murray Krahn, MD, MSc
About this study
Official title: SIESTA: Home Sleep Study With ApneaDx™ for the Diagnosis of Obstructive Sleep Apnea: A Pragmatic Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Portable Sleep Monitor
- Keywords
- obstructive sleep apnea, Portable Monitor, AHI, ESS, Cost effectiveness
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Sleep MonitorDevice
Also called ApneaDx
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 months
Secondary outcomes (1)
To evaluate the cost-effectiveness (cost per quality-adjusted life year) of the OSA
- 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.
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mars, Inc.
- Responsible party
- Principal investigator, Murray Krahn, University of Toronto
- Investigators
- Murray Krahn, MSc, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003729
- Sponsor's protocol ID
- 29539
- Status last verified
- Jun 2015
- First submitted
- 2 Dec 2013
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31707288
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIESTA: Home Sleep Study With ApneaDx™ for the Diagnosis of Obstructive Sleep Apnea: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02003729
- Acronym / sponsor ID
- 29539
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, Portable Monitor, AHI, ESS, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Mars, Inc.
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable Sleep Monitor | Active comparator | Device: Portable Sleep MonitorThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable Sleep MonitorAlso: ApneaDxApneaDx™ is a new PM that uses a microphone to record breath sounds and an acoustical analysis algorithm of breath sounds to determine the AHI. | Device | Portable Sleep Monitor |
Primary outcome
To evaluate the accuracy of the clinical diagnosis of OSA
Time frame: 4-5 months
• 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
• 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.
1 secondary outcome
To evaluate the cost-effectiveness (cost per quality-adjusted life year) of the OSA
Time frame: 4-5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 31707288Fitzpatrick 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.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murray Krahn, MSc, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Sleep Monitor in people with Obstructive Sleep Apnea, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murray Krahn, MD, MSc (416-978-6608, murray.krahn@theta.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the accuracy of the clinical diagnosis of OSA (time frame: 4-5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.