OPTImized RESTing Environments in Rehabilitation (OPTIREST)

May 17, 2022 updated by: Simon Svanborg Kjeldsen, University of Aarhus

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jørgen F Nielsen, MD DMSc, Hammel neurorehabilitation centre and university research clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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