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Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397681
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Aalborg University
Mayo Clinic
Information provided by (Responsible Party):
Danish Pain Research Center

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.

Condition or disease Intervention/treatment Phase
Autonomic Nervous System Diseases Other: Autonomic Function Testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Other: Autonomic Function Testing
Autonomic nervous system index assessed with Task Force Monitor (CNSystems Medizintechnik AG, Graz, Austria)




Primary Outcome Measures :
  1. Blood pressure changes to cardiovascular adrenergic activation [ Time Frame: 3 hours ]
  2. Heart rate changes to parasympathetic activation [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Expiratory pressure during the Valsalva maneuver [ Time Frame: 3 hours ]
  2. Expiratory duration during the Valsalva maneuver [ Time Frame: 3 hours ]
  3. Air volume exchanged per respiratory cycle during deep respiration [ Time Frame: 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male
  • ≥ 18 year
  • normal ECG-12

Exclusion Criteria:

  • any known disease
  • smoking
  • any intake of regular medicine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397681


Locations
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Denmark
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
Aalborg University
Mayo Clinic
Investigators
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Principal Investigator: Astrid J. Terkelsen Danish Pain Research Center
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Responsible Party: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT02397681    
Other Study ID Numbers: AUTO-2015
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Autonomic Nervous System Diseases
Primary Dysautonomias
Nervous System Diseases