Physiological Changes in Deliberate ApneaNCT02280226

Evaluating the Influence of Apnea on Cardiac Function Using Cardiac Magnetic Resonance Imaging.

A study testing magnetic resonance imaging (MRI) in people with Physiological Changes in Deliberate Apnea, run by University Hospital, Bonn.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for: Physiological Changes in Deliberate Apnea
What is being tested?: magnetic resonance imaging (MRI)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: No sites listed yet
Study dates: Apr 2014to Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Being able to hold breath deliberately at least 4,5 minutes

Who cannot join

About this study

Official title: Evaluating the Influence of Apnea on Heart Function With Strain Analysis and Measurement of Fibrosis Derived From T1-mapping Using Cardiac Magnetic Resonance Imaging (MRI).

Former studies revealed a distinct pattern of changes in circulation during deliberate apnea. Blood pressure rises significantly often accompanied by bradycardia. Further studies confirmed a massive increase of total vascular resistance as it also happens in shock to maintain perfusion of heart, lung and brain. This study is to determine the exact alterations of the cardiac function during this reaction, show the redistribution of blood volume in apnea and evaluate possible longterm effects on the central nervous system caused by repeated apnea via magnetic resonance imaging.

Conditions: Physiological Changes in Deliberate Apnea
Being tested: magnetic resonance imaging (MRI)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

magnetic resonance imaging (MRI)Device

Study groups in NCT02280226
Study group	Role	What they receive
Deliberate Apnea Group	Experimental	Subjects undergo maximum apnea. Receives: Device: magnetic resonance imaging (MRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Function: Duration of Apnea
Alteration of cardiac function in subjects undergoing maximum apnea.
Measured: every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements
Mean Blood Flow Measurement Under Apnea Using MRI
Blood flow pattern in subjects undergoing maximum apnea.
Measured: Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jul 2016

First posted31 Oct 2014 (estimated)
Study startApr 2014
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physiological Changes in Deliberate ApneaStudies 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02280226
Sponsor's protocol ID: UBonn-MRI-heart-14
Status last verified: Feb 2018
First submitted: 29 Oct 2014
Last updated: 7 Feb 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Eichhorn L, Doerner J, Luetkens JA, Lunkenheimer JM, Dolscheid-Pommerich RC, Erdfelder F, Fimmers R, Nadal J, Stoffel-Wagner B, Schild HH, Hoeft A, Zur B, Naehle CP. Cardiovascular magnetic resonance assessment of acute cardiovascular effects of voluntary apnoea in elite divers. J Cardiovasc Magn Reson. 2018 Jun 18;20(1):40. doi: 10.1186/s12968-018-0455-x.
PubMed 29909774

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Influence of Apnea on Heart Function With Strain Analysis and Measurement of Fibrosis Derived From T1-mapping Using Cardiac Magnetic Resonance Imaging (MRI).
ClinicalTrials.gov ID: NCT02280226
Acronym / sponsor ID: UBonn-MRI-heart-14
Conditions: Physiological Changes in Deliberate Apnea
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University Hospital, BonnUniversity, hospital or other
Study start: Apr 2014
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 31 Oct 2014 (estimated)
Results: Posted 7 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Deliberate Apnea Group	Experimental	Device: magnetic resonance imaging (MRI)Subjects undergo maximum apnea.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Being able to hold breath deliberately at least 4,5 minutes

Key exclusion criteria (1 listed)

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
magnetic resonance imaging (MRI)	Device	Deliberate Apnea Group

Primary outcome

Cardiac Function: Duration of Apnea
Time frame: every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements
Alteration of cardiac function in subjects undergoing maximum apnea.
Mean Blood Flow Measurement Under Apnea Using MRI
Time frame: Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements
Blood flow pattern in subjects undergoing maximum apnea.

Results and safety

Results posted to the registry on 7 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Deliberate Apnea Group	17	17

Primary outcome: Cardiac Function: Duration of Apnea

Time frame: every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements. Mean (Standard Deviation). Unit: sec

Measure	Deliberate Apnea Group n = 17
Value	483 (582)

Primary outcome: Mean Blood Flow Measurement Under Apnea Using MRI

Time frame: Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements. Mean (Standard Deviation). Unit: ml/s

Measure	Deliberate Apnea Group n = 17
Value	82 (27)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deliberate Apnea Group	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29909774Eichhorn L, Doerner J, Luetkens JA, Lunkenheimer JM, Dolscheid-Pommerich RC, Erdfelder F, Fimmers R, Nadal J, Stoffel-Wagner B, Schild HH, Hoeft A, Zur B, Naehle CP. Cardiovascular magnetic resonance assessment of acute cardiovascular effects of voluntary apnoea in elite divers. J Cardiovasc Magn Reson. 2018 Jun 18;20(1):40. doi: 10.1186/s12968-018-0455-x.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing magnetic resonance imaging (MRI) in people with Physiological Changes in Deliberate Apnea, run by University Hospital, Bonn.

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 1 inclusion and 1 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 7 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cardiac Function: Duration of Apnea (time frame: every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements). 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 NCT02280226, 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 7 Feb 2018.