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CompletedNCT03441009MANS-PSHUpdated Sep 24, 2021

Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH

An observational study in Autonomic Nervous System Imbalance, sponsored by Region MidtJylland Denmark. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Region MidtJylland Denmark · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study summary

Adult patients suffering from acquired brain damage run the risk of developing PSH. This group of patients is admitted to our unit, the Neurointensive Stepdown Unit, at Silkeborg Regional Hospital for intensive care and early neurorehabilitation. After weaning from intensive carethey are transferred to Hammel NeuroCentre.

Aim is to assess whether HRV-derived variables in the frequency domain mirror therapeutic and/or nursing and/or pharmacologic interventions. To the extent clinically available BRS and metabolism are included in the assessment.

Read the detailed description

See report:

Honore H, Eggertsen K, Sondergaard S: A study into the feasibility of using HRV variables to guide treatment in patients with paroxystic sympathetic hyperactivity in a neurointensive step-down unit. NeuroRehabilitation 2019, 44(1):141-155.

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Conditions studied

  • Autonomic Nervous System Imbalance

Keywords

  • PSH, Rehabilitation, Medication, ANS
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In context

Lead sponsor

Region MidtJylland Denmark is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients admitted to NISU from tertiary health care facilities for intensive care in combination with early neurorehabilitation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Symptoms of PSH according to Baguley scoring table

Exclusion criteria

Exclusion Criteria:

No symptoms of PSH

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Interventions

  • OtherPhysio-/occupational therapy

    Physio-/occupational therapy, ADL

    Also known as: Psycotropic medications

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What researchers measure

Primary outcomes

  1. Difference before vs after intervention in frequency domain parameters of HRV

    HRV parameters: low frequency (LF, 0.04-0.15 Hz), high frequency (HF, 0.15-0.4 Hz) in terms of peak frequency (Hz), absolute power (ms2, natural logarithm transformed values of absolute powers of VLF, LF, and HF bands), relative power (absolute power/total power), normalized power (%, normalized units, n.u.), total power given by VLF + HF + LF (ms2) and LF/HF ratio.

    Time frame: immediate

  2. Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions

    Two independent ratings on a 5-point scale, -2 to +2

    Time frame: immediate

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03441009
Lead sponsor
Region MidtJylland Denmark
Responsible party
Soren Sondergaard (Senior Consultant, Region MidtJylland Denmark) — Principal investigator
First posted
Feb 22, 2018
Start date
Jan 2, 2016
Primary completion
Oct 1, 2020
Completion
Oct 1, 2020
Last update
Sep 24, 2021

Study contacts

Jørgen Feldbæk, Professor
study chair · Hammel Neuro- and Research Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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