Breathing ExercisesEPIQNCT02828735
Respiration Patterns With Impedance in LINQ
A study testing respiration assessment in people with Breathing Exercises, run by Medtronic BRC at 1 site in South Africa.
Trial summary
The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing Exercises
- What is being tested?
- respiration assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Africa
- Study dates
- 30 Jan 2017to 20 Nov 2017
- 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
- Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure.
- Chronic Kidney Disease (CKD) in Stage 5 (GFR = <15 mL/min).
- Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible).
- Willing to sign the informed consent form.
- Greater than 18 years of age.
Who cannot join
- Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
- Significant respiratory diseases such as COPD or pulmonary hypertension.
- Frequent arrhythmias, including PVC's.
- Known systolic heart failure.
- Recent infection.
- Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method.
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- Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc).
- Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
- Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest.
- Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes.
- Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor
The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.
- Conditions
- Breathing Exercises
- Being tested
- respiration assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiration assessmentDevice
Respiration Breathing Exercise
| Study group | Role | What they receive |
|---|---|---|
| Respiration assessment | Other | Not described Receives: Device: respiration assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of respiration detection
Respiratory Maneuvers and Device interrogation
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start30 Jan 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mpiko Ntsekhe, Principal investigator, Groote Schuur Hospital, Cape Town, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828735
- Sponsor's protocol ID
- EPIQ
- Acronym
- EPIQ
- Status last verified
- Jun 2018
- First submitted
- 20 Jul 2015
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REspiration Patterns in REVEAL LINQ Insertable Cardiac Monitor
- ClinicalTrials.gov ID
- NCT02828735
- Acronym / sponsor ID
- EPIQ / EPIQ
- Conditions
- Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 12 Jul 2016 (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 purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiration assessment | Other | Device: respiration assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure.
- Chronic Kidney Disease (CKD) in Stage 5 (GFR = <15 mL/min).
- Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible).
- Willing to sign the informed consent form.
- Greater than 18 years of age.
Key exclusion criteria (11 listed)
- Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
- Significant respiratory diseases such as COPD or pulmonary hypertension.
- Frequent arrhythmias, including PVC's.
- Known systolic heart failure.
- Recent infection.
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 |
|---|---|---|
| respiration assessmentRespiration Breathing Exercise | Device | Respiration assessment |
Primary outcome
feasibility of respiration detection
Time frame: up to 18 months
Respiratory Maneuvers and Device interrogation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Breathing Exercises
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Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma
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Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma
Multiple Myeloma (MM), Breathing Techniques
Active, not recruiting
Box Breathing and Physiological Feedback Before Endoscopy
Breathing Exercises, Physiological Feedback
Active, not recruiting
Breathing Exercises for Dyspnea and Anxiety in Heart Failure
Heart Failure, Breathing Exercises
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Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome
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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.
Mpiko Ntsekhe principal investigator
Groote Schuur Hospital, Cape Town, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiration assessment in people with Breathing Exercises, run by Medtronic BRC at 1 site in South Africa.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 21 Jun 2018. 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 South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of respiration detection (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2018.