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OPTImized RESTing Environments in Rehabilitation (OPTIREST)

Primary Purpose

Acquired Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Optimized resting environment
Standard resting environment
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring Quality of rest, Daytime resting periods, Accelerometry, Electrocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regionshospitalet Hammel Neurocenter

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Optimized resting environment

Standard resting environment

Arm Description

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

Standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward.

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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.
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.
Heart rate
The mean/median heart rate of a 0.2 hz reported heart rate as measured by the monitor system Mindray nseries TM80.
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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2020
Last Updated
May 17, 2022
Sponsor
University of Aarhus
Collaborators
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04500951
Brief Title
OPTImized RESTing Environments in Rehabilitation
Acronym
OPTIREST
Official Title
Evaluation and Improvement of Rest Activity Cycles and Rest Quality in Patients With Severe Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Descriptive studies were published based on this record. Randomized Controlled time-series study was discontinued due to infeasability. Descriptive time-series studies and methodological studies have been published.
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Quality of rest, Daytime resting periods, Accelerometry, Electrocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A Randomized controlled time-series study. 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimized resting environment
Arm Type
Experimental
Arm Description
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
Arm Title
Standard resting environment
Arm Type
Other
Arm Description
Standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward.
Intervention Type
Other
Intervention Name(s)
Optimized resting environment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard resting environment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical evaluation of quality of rest
Description
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.
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.
Title
Actigraphic evaluation of motor rest ratio (MRR)
Description
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
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.
Title
Heart rate variability: LF band of the power spectrum of a 256 hz ECG recording
Description
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.
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.
Title
Heart rate variability: HF band of the power spectrum of a 256 hz ECG recording
Description
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.
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.
Title
Heart rate variability: LF/HF ratio of the power spectrum of a 256 hz ECG recording
Description
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.
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.
Title
Heart rate variability: SDNN a time domain estimate of heart rate variability from of a 256 hz ECG recording
Description
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.
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.
Title
Heart rate
Description
The mean/median heart rate of a 0.2 hz reported heart rate as measured by the monitor system Mindray nseries TM80.
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.
Title
Respiratory rate
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørgen F Nielsen, MD DMSc
Organizational Affiliation
Hammel Neurorehabilitation Centre and University Research Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Regionshospitalet Hammel Neurocenter
City
Hammel
ZIP/Postal Code
8450
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not possible due to GDPR and ethics considerations
Links:
URL
https://pure.au.dk/portal/da/projects/evaluation-and-improvement-of-rest-activity-cycles-and-quality-of-rest-in-patients-with-severe-acquired-brain-injury(a4948657-bc8b-455b-bfeb-189e19bf0af3).html
Description
Aarhus University project description site

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OPTImized RESTing Environments in Rehabilitation

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