Back to resultsAutonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
Primary Purpose
Autonomic Nervous System Diseases
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Autonomic Function Testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Autonomic Nervous System Diseases
Eligibility Criteria
Inclusion Criteria:
- male
- ≥ 18 year
- normal ECG-12
Exclusion Criteria:
- any known disease
- smoking
- any intake of regular medicine
Sites / Locations
- Danish Pain Research Center, Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Outcomes
Primary Outcome Measures
Blood pressure changes to cardiovascular adrenergic activation
Heart rate changes to parasympathetic activation
Secondary Outcome Measures
Expiratory pressure during the Valsalva maneuver
Expiratory duration during the Valsalva maneuver
Air volume exchanged per respiratory cycle during deep respiration
Full Information
NCT ID
NCT02397681
First Posted
February 11, 2015
Last Updated
January 30, 2018
Sponsor
Danish Pain Research Center
Collaborators
Aalborg University, Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02397681
Brief Title
Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
Official Title
Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish Pain Research Center
Collaborators
Aalborg University, Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Nervous System Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Autonomic Function Testing
Intervention Description
Autonomic nervous system index assessed with Task Force Monitor (CNSystems Medizintechnik AG, Graz, Austria)
Primary Outcome Measure Information:
Title
Blood pressure changes to cardiovascular adrenergic activation
Time Frame
3 hours
Title
Heart rate changes to parasympathetic activation
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Expiratory pressure during the Valsalva maneuver
Time Frame
3 hours
Title
Expiratory duration during the Valsalva maneuver
Time Frame
3 hours
Title
Air volume exchanged per respiratory cycle during deep respiration
Time Frame
3 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
male
≥ 18 year
normal ECG-12
Exclusion Criteria:
any known disease
smoking
any intake of regular medicine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid J. Terkelsen
Organizational Affiliation
Danish Pain Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Pain Research Center, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
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