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NCT03441009 Clinical Trial

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

Autonomic Nervous System Imbalance Clinical Trial

— MANS-PSH  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03441009
Other study ID # 654865
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2, 2016
Est. completion date October 1, 2020

Study information
Verified date September 2021
Source Region MidtJylland Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Symptoms of PSH according to Baguley scoring table Exclusion Criteria: No symptoms of PSH

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Physio-/occupational therapy
Physio-/occupational therapy, ADL

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Region MidtJylland Denmark

Outcome
Type Measure Description Time frame Safety issue
Primary 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. immediate
Primary Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions Two independent ratings on a 5-point scale, -2 to +2 immediate
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