Effectiveness of the Nordic Sensi Chair in the Treatment of Dementia Behavioral Disorders (NSC-DEMEN)

NCT05706792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-01-31

No results posted yet for this study

Summary

The main objective of this study is to evaluate the effectiveness of the Nordic Sensi® Chair (NSC) in the management of behavioral symptoms of dementia (BPSD) in real clinical practice in people with dementia admitted to nursing homes. The secondary objective of the present study is to assess its benefits on the performance of the daily work activities of care staff.

Although over time the BPSD have been treated predominantly with pharmacological measures, there is now sufficient scientific evidence to support the use of non-pharmacological therapies (NPT) for their management.Within this context, only a few studies have evaluated the use of rocking chairs for people with dementia. Modern rocking chairs may be suitable for long-term care because rocking, a rhythmically repeated movement, can contribute to psychosocial wellbeing .

In this regard, it is a focus of attention to consider the therapeutic role of the Nordic Sensi® Chair in the treatment of BPSD based on its ability to offer patients a sensory experience that brings the benefits of music therapy, therapeutic tactile stimulation, vestibular stimulation, and relaxation in an integrated way, especially those in nursing homes. The NSC is an electrically operated rocking chair with built-in MusiCure music. It is equipped with an integrated audio system with music recording. The NSC has three different programs: Relax for deep relaxation, Refresh for recovery and Comfort for gentle relaxation. In addition to musical programming, the NSC provides predefined tactile stimulation and rocking motion, for a relaxing multi-sensory experience.

In this study, the 20 minutes NSC deep relaxation program (Relax Program) will be used.

Participants are randomly assigned to two groups of equal size: a treatment group that receives three times a week one session per day of 20 minutes in the Relax for deep relaxation program of the NSC and a control group that does not participate in the activity mentioned for the treatment group, but receives, at the same time and duration, the care and activities that are part of the daily routines.

Although cognitive and functional symptoms have been the hallmarks of dementia, in recent years behavioral and psychological symptoms of dementia (BPSD) have become increasingly important. In all cases, BPSD is always one of the most important challenges that both the patient and their caregivers will face throughout the course of the disease.

Conditions

Interventions

DEVICE

Nordic Sensi Chair

The Nordic Sensi Chair is an electrically operated rocking chair with built-in MusiCure music composed by Niels Eje. It is equipped with an integrated audio system with music recording based on more than 15 years of research on the calming and mentally stimulating effect of sound. The Nordic Sensi Chair has three different programs: Relax for deep relaxation, Refresh for recovery and Comfort for gentle relaxation. A 5 kg fiber blanket increases the feeling of security and relaxation, while helping users to perceive their own body. In addition to musical programming, the Nordic Sensi Chair provides predefined tactile stimulation and rocking motion, for a relaxing multi-sensory experience. All settings can be easily customized at the touch of a button. For the purposes of this study, the NSC deep relaxation program (Relax Program) was used.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Principal Investigators

  • Jose Maria Garcia-Alberca, MD, PhD · Instituto Andaluz de Neurociencia (IANEC), 17 Álamos Street, 29012 Málaga, Spain

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2022-09-20
Completion
2022-09-20

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05706792 on ClinicalTrials.gov