Acquired Brain InjuryOPTIRESTNCT04500951
OPTImized RESTing Environments in Rehabilitation
A study testing Optimized resting environment and Standard resting environment in people with Acquired Brain Injury, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Optimized resting environment and Standard resting environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- 20 May 2020to 2 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Admitted due to polyneuropathies e.g. Guillain-Barré
- Terminal illness
- Spinal lesions
- Expected stay < 3 weeks
- Paroxysmal Sympathetic Hyperactivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acquired Brain Injury
- Being tested
- Optimized resting environment, Standard resting environment
- Keywords
- Quality of rest, Daytime resting periods, Accelerometry, Electrocardiography
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized resting environmentOther
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.
Standard resting environmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimized resting environment | Experimental | 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 Receives: Other: Optimized resting environment |
| Standard resting environment | Other | Standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward. Receives: Other: Standard resting environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start20 May 2020
- Primary completion28 Apr 2021
- Study completion2 Feb 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Simon Svanborg Kjeldsen, University of Aarhus
- Investigators
- Jørgen F Nielsen, MD DMSc, Study director, Hammel Neurorehabilitation Centre and University Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500951
- Sponsor's protocol ID
- 80
- Other IDs
- 1-10-72-32-18, 1-10-72-32-18
- Acronym
- OPTIREST
- Status last verified
- May 2022
- First submitted
- 5 May 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not possible due to GDPR and ethics considerations
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Improvement of Rest Activity Cycles and Rest Quality in Patients With Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT04500951
- Acronym / sponsor ID
- OPTIREST / 80
- Conditions
- Acquired Brain Injury
- Keywords
- Quality of rest, Daytime resting periods, Accelerometry, Electrocardiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 20 May 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Optimized resting environment | Experimental | Other: Optimized resting environmentThe 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 | Other | Other: Standard resting environmentStandard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- Admitted due to polyneuropathies e.g. Guillain-Barré
- Terminal illness
- Spinal lesions
- Expected stay < 3 weeks
- Paroxysmal Sympathetic Hyperactivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized resting environmentAlarms 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 | Optimized resting environment |
| Standard resting environmentThe 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. | Other | Standard resting environment |
Primary outcome
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.
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
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: 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 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: 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.
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.
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.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Aarhus University project description siteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not possible due to GDPR and ethics considerations
Related trials for Acquired Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
RecruitingObservational study
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Small Cell Lung Cancer ( SCLC ), Brain Injury
Not yet recruitingObservational study
Description of Clinicians' Predictive Abilities Before and After a Diffusion Tensor Imaging (DTI)
Diffusion Tensor Imaging Prognosis, Brain Injury, Traumatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørgen F Nielsen, MD DMSc study director
Hammel Neurorehabilitation Centre and University Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized resting environment and Standard resting environment in people with Acquired Brain Injury, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.