OPTImized RESTing Environments in Rehabilitation (OPTIREST)

Evaluation and Improvement of Rest Activity Cycles and Rest Quality in Patients With Severe Acquired Brain Injury

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.

Study Overview

• Status: Terminated
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Other: Optimized resting environment; Other: 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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hammel, Denmark, 8450
    • Regionshospitalet Hammel Neurocenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Optimized resting environment; Alarms from feeding pumps will be relayed to the nurse call system for all intervention periods. Alternatively meals will be timewise reorganized to not interfer with the intervention resting periods. Signs reminding staff not to disturb will be posted for all intervention periods. For each patient the close team of rehabilitation professionals will agree upon a guideline suggesting the optimal resting environment for the specific patient. The guideline wil be based on knowledge gathered from relatives on pre-injury preferences. Furthermore, the guideline will be developed based on a toolbox of possible intervention representing best practice. The toolbox has been designed according to the categories of the International Classification of Functioning. The intervention will designed individually for each patient.
Other: 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.	Other: Standard resting environment; The control condition, standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward. Pressure ulcers and positioning believed to induce pain will be avoided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluation of quality of rest	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.	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.
Actigraphic evaluation of motor rest ratio (MRR)	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	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.
Heart rate variability: LF band of the power spectrum of a 256 hz ECG recording	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.	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.
Heart rate variability: HF band of the power spectrum of a 256 hz ECG recording	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.	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.
Heart rate variability: LF/HF ratio of the power spectrum of a 256 hz ECG recording	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.	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.
Heart rate variability: SDNN a time domain estimate of heart rate variability from of a 256 hz ECG recording	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.	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.
Heart rate	The mean/median heart rate of a 0.2 hz reported heart rate as measured by the monitor system Mindray nseries TM80.	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.
Respiratory rate	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.	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.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aalborg University
• Investigators: Study Director: Jørgen F Nielsen, MD DMSc, Hammel neurorehabilitation centre and university research clinic

Publications and helpful links

Helpful Links

• Aarhus University project description site

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): February 2, 2022

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Accelerometry; Electrocardiography; Quality of rest; Daytime resting periods
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 80; 1-10-72-32-18 (Other Identifier: Data protection agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not possible due to GDPR and ethics considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No