Autonomic Nervous System DiseasesNCT02397681
Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
A study testing Autonomic Function Testing in people with Autonomic Nervous System Diseases, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effects of procedural differences during the Valsalva maneuver and deep breathing test in autonomic nervous system testing. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Diseases
- What is being tested?
- Autonomic Function Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Aug 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- ≥ 18 year
- normal ECG-12
Who cannot join
- any known disease
- smoking
- any intake of regular medicine
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
The purpose of this study is to determine the effects of procedural differences during the Valsalva maneuver and deep breathing test in autonomic nervous system testing.
- Conditions
- Autonomic Nervous System Diseases
- Being tested
- Autonomic Function Testing
- Medical subject headings
- Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic Function TestingOther
Autonomic nervous system index assessed with Task Force Monitor (CNSystems Medizintechnik AG, Graz, Austria)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Autonomic Function Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure changes to cardiovascular adrenergic activation
Measured: 3 hours
Heart rate changes to parasympathetic activation
Measured: 3 hours
Secondary outcomes (3)
Expiratory pressure during the Valsalva maneuver
Measured: 3 hours
Expiratory duration during the Valsalva maneuver
Measured: 3 hours
Air volume exchanged per respiratory cycle during deep respiration
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DiseasesStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Astrid J. Terkelsen, Principal investigator, Danish Pain Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397681
- Sponsor's protocol ID
- AUTO-2015
- Status last verified
- Jan 2018
- First submitted
- 11 Feb 2015
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
- ClinicalTrials.gov ID
- NCT02397681
- Acronym / sponsor ID
- AUTO-2015
- Conditions
- Autonomic Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- Aalborg University, Mayo Clinic
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Mar 2015 (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 this study is to determine the effects of procedural differences during the Valsalva maneuver and deep breathing test in autonomic nervous system testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Autonomic Function Testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male
- ≥ 18 year
- normal ECG-12
Key exclusion criteria (3 listed)
- any known disease
- smoking
- any intake of regular medicine
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 |
|---|---|---|
| Autonomic Function TestingAutonomic nervous system index assessed with Task Force Monitor (CNSystems Medizintechnik AG, Graz, Austria) | Other | Experimental |
Primary outcome
Blood pressure changes to cardiovascular adrenergic activation
Time frame: 3 hours
Heart rate changes to parasympathetic activation
Time frame: 3 hours
3 secondary outcomes
Expiratory pressure during the Valsalva maneuver
Time frame: 3 hours
Expiratory duration during the Valsalva maneuver
Time frame: 3 hours
Air volume exchanged per respiratory cycle during deep respiration
Time frame: 3 hours
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 31 Jan 2018.
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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.
Astrid J. Terkelsen principal investigator
Danish Pain Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autonomic Function Testing in people with Autonomic Nervous System Diseases, run by Danish Pain Research Center at 1 site in Denmark.
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 3 inclusion and 3 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 31 Jan 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 Denmark. 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?
Blood pressure changes to cardiovascular adrenergic activation (time frame: 3 hours). 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?
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 31 Jan 2018.