OPTImized RESTing Environments in Rehabilitation (OPTIREST)

University of Aarhus

Status: Terminated

Conditions: Acquired Brain Injury

Treatments: Other: Standard resting environment; Other: Optimized resting environment

Study type: Interventional

Funder types: Other

Identifiers

NCT04500951

80

1-10-72-32-18 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Optimized resting environment

Experimental group

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

Treatment:

Other: Optimized resting environment

Standard resting environment

Other group

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.

Treatment:

Other: Standard resting environment