Evaluation and Improvement of Rest Activity Cycles and Rest Quality in Patients With Severe Acquired Brain Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Aarhus
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Heart rate variability: LF band of the power spectrum of a 256 hz ECG recording
Study Overview
Brief Summary
This study investigates whether an individually designed environment can support and improve the quality of daytime resting periods in in-hospital neurorehabilitation of patients suffering severe acquired brain injury.
The effect of a individually optimized resting environment will be tested against a standard resting environment.
Detailed Description
Aim:
The aim is to identify differences in quality of rest as reflected by clinical evaluation, pulse rate, motor activity and autonomic balance between the optimized resting environment (ORE) and the standard resting environment (SR).
Method: A Randomized controlled time-series study. Randomization to either SR or ORE for each of the 9 resting periods during a three-day recording session. A period of three days will allow collection of sufficient data. This will also allow the analysis to take the random effects of time and weekday into account. Outcome measures will be differences in mean heart rate during daytime resting periods, aggregated measures of heart rate variability and proportion of resting minutes according to accelerometry.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe Acquired brain injury
- •>= 18 years
- •Relatives/Surrogate can give informed consent
- •Classified as being ≤ 7 on the level of cognitive functions scale (also known as Rancho Los Amigos Scale)
Exclusion Criteria
- •Admitted due to polyneuropathies e.g. Guillain-Barré
- •Terminal illness
- •Spinal lesions
- •Expected stay < 3 weeks
- •Paroxysmal Sympathetic Hyperactivity
Outcomes
Primary Outcomes
Heart rate variability: LF band of the power spectrum of a 256 hz ECG recording
Time Frame: Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
The mean or median (Depending on distribution) low frequency power spectrum of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.
Heart rate variability: LF/HF ratio of the power spectrum of a 256 hz ECG recording
Time Frame: Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
The mean or median (Depending on distribution) LF/HF ratio of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.
Heart rate variability: HF band of the power spectrum of a 256 hz ECG recording
Time Frame: Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
The mean or median (Depending on distribution) High frequency power spectrum of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.
Heart rate
Time Frame: Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
The mean/median heart rate of a 0.2 hz reported heart rate as measured by the monitor system Mindray nseries TM80.
Clinical evaluation of quality of rest
Time Frame: Measurement represent the evaluated quality of rest for the duration of the resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
A five option categorical scale going from "really bad"-"bad"-"good"-"really good "+ the option of "insufficient information for evaluation". Evaluation is performed by the patient responsible clinician at the end of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period.
Heart rate variability: SDNN a time domain estimate of heart rate variability from of a 256 hz ECG recording
Time Frame: Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
The mean or median (Depending on distribution) SDNN of all epochs for the duration of the resting periods will be used to characterize the balance in the autonomous nervous system.
Respiratory rate
Time Frame: Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
The mean/median respiratory rate of a 0.2 hz reported respiratory rate as extrapolated by the monitor system Mindray nseries TM80 from a 256 hz ecg.
Actigraphic evaluation of motor rest ratio (MRR)
Time Frame: Continuous data will be aggregated from the duration of each resting period. Duration of resting periods will be varying according to the needs of the patients for each resting period. Estimated to be 30 minutes to 2½ hours.
Actigraphy will be measured during all resting periods. Epochs of 1 minute will be defined as active or inactive based on previous used limits. Motor rest ratio (MRR) defined as the proportions of minutes defined as resting out of all minutes recorded in each resting periods will be used to describe degree of motor rest
Secondary Outcomes
No secondary outcomes reported
Investigators
Simon Svanborg Kjeldsen
PhD Student
University of Aarhus