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

Completed

• Conditions: Autonomic Nervous System Imbalance

• Registration Number: NCT03441009
• Lead Sponsor: Region MidtJylland Denmark

Brief 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.

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.

Study Timeline

• Study Start: 2016-01-02
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-22
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Symptoms of PSH according to Baguley scoring table

Exclusion Criteria

No symptoms of PSH

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions	immediate	Two independent ratings on a 5-point scale, -2 to +2
Difference before vs after intervention in frequency domain parameters of HRV	immediate	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.