NCT02397681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

February 11, 2015

Last Update Submit

January 30, 2018

Conditions

Autonomic Nervous System Diseases

Outcome Measures

Primary Outcomes (2)

  • Blood pressure changes to cardiovascular adrenergic activation

    3 hours

  • Heart rate changes to parasympathetic activation

    3 hours

Secondary Outcomes (3)

  • Expiratory pressure during the Valsalva maneuver

    3 hours

  • Expiratory duration during the Valsalva maneuver

    3 hours

  • Air volume exchanged per respiratory cycle during deep respiration

    3 hours

Study Arms (1)

Experimental

EXPERIMENTAL
Other: Autonomic Function Testing

Interventions

Autonomic Function TestingOTHER

Autonomic nervous system index assessed with Task Force Monitor (CNSystems Medizintechnik AG, Graz, Austria)

Experimental

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • ≥ 18 year
  • normal ECG-12

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Astrid J. Terkelsen

    Danish Pain Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

March 25, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

DK(1)