CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Nordic Sensi Chairdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05706792
NCT05706792N/ACompleted

Randomized Controlled Clinical Trial to Evaluate the Effectiveness of the Nordic Sensi Chair in the Treatment of Dementia Behavioral Disorders (NSC-DEMEN Study)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·interventional·Posted Jan 31, 2023·Updated Jan 31, 2023

In Brief

A clinical study evaluating Nordic Sensi Chair for Dementia. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 31, 2023
Enrollment StartMay 20, 2022
Primary CompletionSep 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 3.4 years ago

Interventions

Nordic Sensi Chairdevice

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.