Clinical trial NCT04500951: OPTImized RESTing Environments in Rehabilitation
Official title: Evaluation and Improvement of Rest Activity Cycles and Rest Quality in Patients With Severe Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Quality of rest
Daytime resting periods
Accelerometry
Electrocardiography
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2020-08-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical evaluation of quality of rest
timeFrame: 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.
measure: Actigraphic evaluation of motor rest ratio (MRR)
timeFrame: 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.
measure: Heart rate variability: LF band of the power spectrum of a 256 hz ECG recording
timeFrame: 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.
measure: Heart rate variability: HF band of the power spectrum of a 256 hz ECG recording
timeFrame: 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.
measure: Heart rate variability: LF/HF ratio of the power spectrum of a 256 hz ECG recording
timeFrame: 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.
measure: Heart rate variability: SDNN a time domain estimate of heart rate variability from of a 256 hz ECG recording
timeFrame: 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.
measure: Heart rate
timeFrame: 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.
measure: Respiratory rate
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Regionshospitalet Hammel Neurocenter
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University Research Clinic
name: Jørgen F Nielsen, MD DMSc
role: STUDY_DIRECTOR
References: