Plain English Summary
Current plain English summary as of 12/09/2019:
Background and study aims
Chronic changes in arterial oxygen concentration are used as a measure of severity of disease state for a variety of conditions such as sleep apnea, chronic obstructive pulmonary disease, pulmonary arterial hypertension and heart failure. The aim of this study is to get information about how much oxygen can be detected in the tissues of the chest and the fingers of patients with two or more of these conditions. These conditions lower the amount of oxygen in the body. Doctors use measurements of how much oxygen is in the blood to understand how severe someone’s condition is. The more doctors know about changes to a person’s blood oxygen levels, the earlier they can treat the condition and this can help to keep more people out of the hospital.
Who can participate?
Patients over the age of 18 with one or more of the following conditions: sleep apnea, chronic obstructive pulmonary disease, pulmonary arterial hypertension and heart failure.
What does the study involve?
In order to collect the necessary data for this study, tissue oxygen sensors are placed on the patient's chest and depending on the condition they possess, the patient either undergoes a monitored sleep study or a series of 6-minute walk tests. The data collection visit takes place at a hospital and lasts about 9 hours for sleep study patients and about 45 minutes for 6-minute walk test patients.
What are the possible benefits and risks of participating?
In agreeing to be in this study, there will not be any direct medical benefits. The information from this study may benefit other patients who need monitoring devices for conditions like these in the future. All the risks of using the study devices and having the sleep study or doing a 6-minute walk test are the same whether patients are in the study or not. These risks include, but are not limited to: skin irritation or rash from the adhesives used to attach the sensors to the chest, skin irritation or rash from the adhesive or Velcro that may be used to keep the sensor wires in place for participants doing a sleep study, and for participants doing a sleep study, the wires from the monitor could pose a risk for strangulation.
Where is the study run from?
1. University of Minnesota (USA)
2. Minneapolis Heart Institute (USA)
When is the study starting and how long is it expected to run for?
May 2019 to February 2020 (updated 09/03/2020, previously: March 2020)
Who is funding the study?
Medtronic (USA)
Who is the main contact?
1. Troy Penz
troy.d.penz@medtronic.com
2. Joy Aso
joy.a.aso@medtronic.com
Previous plain English summary:
Background and study aims
Chronic changes in arterial oxygen concentration are used as a measure of severity of disease state for a variety of conditions such as sleep apnea, chronic obstructive pulmonary disease, pulmonary arterial hypertension and heart failure. The aim of this study is to get information about how much oxygen can be detected in the tissues of the chest and the fingers of patients with two or more of these conditions. These conditions lower the amount of oxygen in the body. Doctors use measurements of how much oxygen is in the blood to understand how severe someone’s condition is. The more doctors know about changes to a person’s blood oxygen levels, the earlier they can treat the condition and this can help to keep more people out of the hospital.
Who can participate?
Patients over the age of 18 with two or more of the following conditions: sleep apnea, chronic obstructive pulmonary disease, pulmonary arterial hypertension and heart failure.
What does the study involve?
In order to collect the necessary data for this study, tissue oxygen sensors are placed on the patient's chest and depending on the condition they possess, the patient either undergoes a monitored sleep study or a series of 6-minute walk tests. The data collection visit takes place at a hospital and lasts about 9 hours for sleep study patients and about 45 minutes for 6-minute walk test patients.
What are the possible benefits and risks of participating?
In agreeing to be in this study, there will not be any direct medical benefits. The information from this study may benefit other patients who need monitoring devices for conditions like these in the future. All the risks of using the study devices and having the sleep study or doing a 6-minute walk test are the same whether patients are in the study or not. These risks include, but are not limited to: skin irritation or rash from the adhesives used to attach the sensors to the chest, skin irritation or rash from the adhesive or Velcro that may be used to keep the sensor wires in place for participants doing a sleep study, and for participants doing a sleep study, the wires from the monitor could pose a risk for strangulation.
Where is the study run from?
1. University of Minnesota (USA)
2. Minneapolis Heart Institute (USA)
When is the study starting and how long is it expected to run for?
May 2019 to January 2020
Who is funding the study?
Medtronic (USA)
Who is the main contact?
1. Troy Penz
troy.d.penz@medtronic.com
2. Joy Aso
joy.a.aso@medtronic.com
Trial website
Contact information
Type
Public
Primary contact
Mr Troy Penz
ORCID ID
Contact details
8200 Coral Sea Street NE
Mounds View
55112
United States of America
+1 (0)763 337 2477
troy.d.penz@medtronic.com
Type
Public
Additional contact
Miss Joy Aso
ORCID ID
Contact details
8200 Coral Sea Street NE
Mounds View
55112
United States of America
+1 (0)401 545 4454
joy.a.aso@medtronic.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
MDT19020
Study information
Scientific title
Tissue oxygen saturation measurement during arterial desaturation study
Acronym
TO-SMART
Study hypothesis
The purpose of this clinical feasibility, observational study is to collect tissue oxygen saturation (StO2) data in the pectoral region while simultaneously collecting peripheral capillary oxygen saturation (SpO2) data in patients with the following morbidities: Sleep Apnea (SA), Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Arterial Hypertension (PAH) and Heart Failure (HF).
Ethics approval
1. Approved 26/11/2019, University of Minnesota Institutional Review Board (McNamara Alumni Center- Suite 350-2, 200 Oak St. SE, Minneapolis, MN 55455, USA)
2. Approved 14/10/2019, Advarra Institutional Review Board (Advarra, 6940 Columbia Gateway Dr Ste 110, Columbia, MD 21046-2788 USA), ref: MOD00520835
Study design
Prospective multi-center non-randomized acute feasibility clinical study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web, please use contact details to request a participant information sheet
Condition
Sleep apnea (SA), chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH) and heart failure (HF)
Intervention
The researchers are targeting four patient populations: SA, COPD, PAH and HF. The COPD/PAH/HF cohort will consist of subjects aged ≥ 18 years who are scheduled to undergo a standard of care (SOC) six-minute walk test (6MWT) and are expected to experience a minimum of 5% arterial oxygen desaturation. The Sleep Apnea cohort will consist of subjects aged ≥ 18 years who are scheduled to undergo a SOC sleep study at a sleep lab and are expected to experience a minimum of 5% arterial oxygen desaturation.
At the enrolment and baseline visit, patients sign the informed consent form (ICF) and their physician collects data pertaining to demographic and health history. This will be when the attending physician assesses if the patient is a good fit for the study. During the data collection visit, tissue oxygen saturation (StO2) and peripheral capillary oxygen saturation (SpO2) will be observed and measured in the patients using sensors. Sleep apnea patients will undergo a sleep study as a means for data collection whereas the COPD/PAH/HF will undergo a series of standard of care 6 Minute Walk Tests. The sleep study and necessary data collection will last approximately 9 hours, whereas the 6 Minute Walk Tests with necessary data collection will run for approximately 45 minutes. At the end of the data collection visit, the subject is able to exit the study. No further follow-up will be required.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Tissue oxygen saturation (StO2) in the pectoral region during tissue oxygen desaturation, measured using external StO2 sensors at a single timepoint
Secondary outcome measures
Standard peripheral capillary oxygen saturation (SpO2), measured using an external SpO2 sensor at a single timepoint
Overall trial start date
01/05/2019
Overall trial end date
17/02/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Subject must be ≥ 18 years old
2. Subject (or subject’s legally authorized representative) is willing and able to provide written informed consent
3. Sleep Apnea cohort: subjects undergoing a scheduled SOC sleep study who are expected to experience a minimum of 5% arterial oxygen desaturation
4. COPD/PAH/HF cohort: subjects undergoing a scheduled SOC 6MWT who are expected to experience a minimum of 5% arterial oxygen desaturation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Total final enrolment
33
Participant exclusion criteria
1. Subject has other medical conditions that would limit study participation (per physician discretion)
2. Subject has known allergies to medical adhesives and cannot tolerate placement of NoninTM SenSmartTM EQUANOXTM Advance sensor on chest
3. Subject has a disorder causing poor blood circulation to the fingers or a connective tissue disorder that would interfere with an accurate measurement of SpO2 in the fingers (per physician discretion)
4. Subject is unable or unwilling to participate in study procedures
5. Subject is enrolled in a concurrent study that may confound the results of this study. Co-enrollment is any concurrent clinical study (including registries) requires approval of the study manager or designee
6. Subject with exclusion criteria required by local law
Recruitment start date
01/10/2019
Recruitment end date
17/02/2020
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Minnesota
717 Delaware Street SE
Minneapolis
55414
United States of America
Trial participating centre
Minneapolis Heart Institute
13205 Isle Drive Suite 100
Baxter
56425
United States of America
Sponsor information
Organisation
Medtronic Inc
Sponsor details
8200 Coral Sea Street NE
Mounds View
55112
United States of America
+1 (0)763 337 2477
troy.d.penz@medtronic.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Medtronic
Alternative name(s)
Medtronic Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Currently there are no plans for publication of this study outside of ISRCTN.com. No additional documents for this study will be made available.
IPD sharing statement
No patient data will be made openly available. It will be stored entirely in a Medtronic controlled database for internal use.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
See additional file ISRCTN30656608_BasicResults_03Jun20.pdf
Publication list
Publication citations
Additional files
- ISRCTN30656608_BasicResults_03Jun20.pdf Uploaded 03/06/2020