NCT02783105

Brief Summary

Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients. PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a worse outcome. Classical music was shown to reduce autonomic nervous system imbalance in healthy people and in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured patients presenting with PSH, as well. Our study aims at demonstrating that early musical intervention, started with the weaning of sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic hyperactivity in traumatic brain-injured patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

November 20, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

May 23, 2016

Last Update Submit

November 8, 2021

Conditions

Paroxysmal Sympathetic Hyperactivity

Keywords

Music therapyParoxysmal sympathetic hyperactivityTraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29)

    The PSH-AM combines the sum of Clinical Features Scale \[CFS\] (from 0 to 18) and the Diagnostic Likelihood tool \[DLT\] (from 0 to 11)

    from desedation (Day 0) to Day 21.

Secondary Outcomes (7)

  • Area under the Clinical Features Scale curve

    from Day 0 to Day 21.

  • Mean Analgesia Nociception Index

    from Day 0 to Day 21.

  • Neurological Pupil Index

    from Day 0 to Day 21.

  • Pain (Critical-Care Pain Observation Tool)

    from Day 0 to Day 21.

  • Neurological outcome (Wessex Head Injury Matrix)

    from Day 0 to Day 21.

  • +2 more secondary outcomes

Study Arms (2)

Musical intervention

EXPERIMENTAL

Music is provided through headphones: Two 30-min musical sessions per day (one in the morning and one in the evening) beginning at the onset of desedation (Day 0) until day 21. Both have inverted "U" shape.

Other: Musical intervention

Control

SHAM COMPARATOR

Patients wear headphones twice a day during 30 minutes, starting at the onset of desedation (Day 0) until day 21, but no music is provided (blank playlist): Sham

Other: Control

Interventions

Musical interventionOTHER
Musical intervention
ControlOTHER

Patients wear headphones twice a day during 30 minutes, starting at the onset of desedation (Day 0) until day 21, but no music is provided (blank playlist): Sham

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe traumatic brain injury (either initial Glasgow Coma Scale \< 8 or intracranial pressure \> 20mmHg for more than 20 min)
  • National health service coverage
  • Informed consent signed by next of kin

You may not qualify if:

  • Non-traumatic brain injury
  • Conditions interfering with measures: bilateral fixed pupils, temporal bone fracture including acoustic channel, eye trauma, previous eye surgery, otorrhagia, hypoacusis,
  • Preexisting autonomic nervous system imbalance: severe diabetes, arrhythmias, pace maker, implantable defibrillator, cardiac transplantation
  • Respiratory rate \< 9/min
  • Patient subject to guardianship or wardship
  • Pregnant or breastfeeding woman
  • Current participation in another biomedical research protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie Réanimation- Hôpital de Hautepierre

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 26, 2016

Study Start

November 20, 2016

Primary Completion

January 4, 2019

Study Completion

December 18, 2019

Last Updated

November 17, 2021

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)