Condition category
Not Applicable
Date applied
21/08/2019
Date assigned
09/09/2019
Last edited
12/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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 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


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

Submission pending - University of Minnesota Institutional Review Board and Advarra Institutional Review Board

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

01/01/2020

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

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

29/11/2019

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)

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)

Publication list

Publication citations

Additional files

Editorial Notes

12/09/2019: The plain English summary was updated.