The Effect of Auditory Stimuli on Heart Rate Variability (HRV) During Resting and During Physical Activity Among Patients With Acquired Brain Injury (ABI)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Sheba Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Heart Rate Variability
Study Overview
Brief Summary
Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an external stimuli. The aim of this system is to maintain homeostasis.The variability implies on the interaction between the sympathetic and the parasympathetic systems to maintain the ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be a damage to the Central Nervous System (CNS) function. The damages described in the literature are cognitive, motor and behavioural function, while there is less relation to the autonomic system. The autonomic system can influence the ability of patient with ABI to participate in the rehabilitation program. The aim of this work is to investigate the activity of the autonomic system activity as manifested by HRV among patients with ABI in different conditions: resting, during activity and while listening to different auditory stimuli.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •2-4 months from acceptance to rehabilitation medical stable
Exclusion Criteria
- •medical unstable a significant hearing deficit premorbid neurological or mental condition
Arms & Interventions
Controls
Auditory stimuli for control group
Intervention: Auditory Stimuli (Other)
Acquired Brain Injury
auditory stimuli for ABI group
Intervention: Auditory Stimuli (Other)
Outcomes
Primary Outcomes
Heart Rate Variability
Time Frame: first measurement: 2 weeks to 2 months from hospitalization to the department: 24 hours EKG follow up for HRV base line. Last measurement: before the release from rehabilitation (up to 12 months).
Heart Rate Variability as measured by HOLTER EKG during the 4 different conditions: first measuerement 2-8 weeks from hospitalization in the TBI rehabilitation department-24 hours detection for HRV baseline. Second measurement: a week after: EKG during the 4 conditions. Third measurement:a month after the first measure, Fourth measurement: 2 months after the first one. Last measurement: Before the release home from rehabilitation (up to one year from the first measurement).
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Ofer Keren
The head of the TBI rehabilitation department
Sheba Medical Center