OPTImized RESTing Environments in Rehabilitation

Not Applicable

Terminated

• Conditions: Acquired Brain Injury
• Interventions: Other: Standard resting environment; Other: Optimized resting environment

• Registration Number: NCT04500951
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-05
• Study Start: 2020-05-20
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Primary Completion: 2021-04-28
• Study Completion: 2022-02-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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)

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Exclusion Criteria

• Admitted due to polyneuropathies e.g. Guillain-Barré
• Terminal illness
• Spinal lesions
• Expected stay < 3 weeks
• Paroxysmal Sympathetic Hyperactivity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard resting environment	Standard resting environment	Standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward.
Optimized resting environment	Optimized resting environment	The optimized resting environment will consist of the following complex intervention. * Technically assisted noise control in regards of alarms in the patient room * Visual signing reminding staff that the patient is not to be disturbed during rest * Individual optimization of room environment according to information received from relatives * Individual optimization of room environment and positioning according to systematized knowledge on best practice in the intervention ward including auditory and visual stimuli

Primary Outcome Measures

Name	Time	Method
Heart rate variability: LF band of the power spectrum of a 256 hz ECG recording	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	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	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	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	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	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	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)	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

Trial Locations

Locations (1)

Regionshospitalet Hammel Neurocenter; 🇩🇰 Hammel, Denmark