Autonomic Nervous System ImbalanceMANS-PSHNCT03441009
Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH
An observational study of Autonomic Nervous System Imbalance, run by Region MidtJylland Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Nervous System Imbalance
- What is being tested?
- Physio-/occupational therapy
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2016to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted to NISU from tertiary health care facilities for intensive care in combination with early neurorehabilitation
Who may be able to join
- Symptoms of PSH according to Baguley scoring table
Who cannot join
- No symptoms of PSH
About this study
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.
- Conditions
- Autonomic Nervous System Imbalance
- Being tested
- Physio-/occupational therapy
- Keywords
- PSH, Rehabilitation, Medication, ANS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physio-/occupational therapyOther
Also called Psycotropic medications
Physio-/occupational therapy, ADL
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate
Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions
Two independent ratings on a 5-point scale, -2 to +2
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start2 Jan 2016
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System ImbalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region MidtJylland Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soren Sondergaard, Region MidtJylland Denmark
- Investigators
- Jørgen Feldbæk, Professor, Study chair, Hammel Neuro- and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441009
- Sponsor's protocol ID
- 654865
- Acronym
- MANS-PSH
- Status last verified
- Sep 2021
- First submitted
- 9 Feb 2018
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH
- ClinicalTrials.gov ID
- NCT03441009
- Acronym / sponsor ID
- MANS-PSH / 654865
- Conditions
- Autonomic Nervous System Imbalance
- Keywords
- PSH, Rehabilitation, Medication, ANS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Region MidtJylland DenmarkUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to NISU from tertiary health care facilities for intensive care in combination with early neurorehabilitation
Key inclusion criteria (1 listed)
- Symptoms of PSH according to Baguley scoring table
Key exclusion criteria (1 listed)
- No symptoms of PSH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physio-/occupational therapyAlso: Psycotropic medicationsPhysio-/occupational therapy, ADL | Other | – |
Primary outcome
Difference before vs after intervention in frequency domain parameters of HRV
Time frame: 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.
Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions
Time frame: immediate
Two independent ratings on a 5-point scale, -2 to +2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørgen Feldbæk, Professor study chair
Hammel Neuro- and Research Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Nervous System Imbalance, run by Region MidtJylland Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference before vs after intervention in frequency domain parameters of HRV (time frame: immediate). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.