The application of music in people with dementia is based on the ancestral link between sounds and the human being and its potential to evoke the memory of events and emotions experienced throughout their lives, while generating states of calm and relaxation. The use of music in people with dementia can be carried out throughout the different stages of the disease, as the patient retains receptivity to music and the ability to listen, sing or hum songs and follow simple rhythms until the most advanced stages of dementia. This fact can be used to maximum benefit for these people, as music can become a way of expressing their emotions in daily life, thus preventing the onset of anxious, agitated or even aggressive behavior.
Another way to increase the comfort of patients is to provide tactile stimulation. This is based on the results of studies showing that peripheral tactile stimulation could activate higher-order brain structures, such as the hypothalamus. As a result, patients would feel less depressed, less anxious, calmer and more alert, while improving their personal and spatial orientation. These benefits would contribute to patients showing more interest in social contacts and participating more in activities of daily living, resulting in improved affective behavior.
In view of the foregoing, it is a focus of much attention to consider the therapeutic role of the Wellness Sensi Chair in the treatment of behavioral and psychological symptoms of dementia (BPSD) based on its ability to offer patients, in an integrated way, a sensory experience that brings the benefits of music therapy, therapeutic tactile stimulation, vestibular stimulation, multi-sensory stimulation and relaxation.
HYPOTHESIS AND OBJECTIVES
It is hypothesized that the use of the Wellness Sensi Chair will improve BPSD, mainly the more disruptive ones such as agitation, aggressiveness, irritability, anxiety or aberrant motor behavior. Thus, this study aims to answer three main questions:
- Could the Wellness Sensi Chair be considered a new non-pharmacological therapy modality to sucessfully manage BPSD in people suffering from dementia?
- How long do its beneficial effects on BPSD last?
- Could the Wellness Sensi Chair play a role in the wellbeing and psychological distress of dementia patients caregivers?
To study the effectiveness of the Nordic Sensi Chair in the management of BPSD in patients with dementia in real clinical practice in patients admitted to nursing homes.
To study the benefits of the Nordic Sensi Chair on the cognitive functioning and quality of life of patients, as well as on the disruption in the development of their professional activities.
Promoter center: Instituto Andaluz de Neurociencia (IANEC), Malaga, Spain.
Arjo Huntleigh, Malmö, Sweden.
Wellness Nordic, Humlebæk, Denmark.
Centro Residencial Almudena, Rincón de la Victoria, Málaga, Spain.
Residencia DomusVi Fuentesol, Alhaurín de la Torre, Málaga, Spain.
Overall study design
A 16-week, controlled, randomized, single-blinded, controlled clinical trial will be conducted. The study includes two groups of subjects: a treatment group that will receive three times a week one session per day of 20 minutes of duration in the Relax program of the Nordic Sensi Chair and a control group that will receive simultaneously, at the same time and duration, the care and activities that are part of the daily routines of the center.
The 16-week study duration includes a first pre-treatment evaluation period of 2 weeks prior to the start of the intervention (phase A), followed by a second 12-week Nordic Sensi Chair intervention period (phase B) and, finally, a third post-treatment evaluation period carried out 2 weeks after the end of the intervention phase (phase C). During phase A all participants will be evaluated in order to establish the baseline of the study. During phase B the intervention will be conducted, with patients randomly assigned to treatment or control group. Participant assessments will be performed at the 6th and 12th week of the intervention period. During phase C, a fourth evaluation of all participants who have completed their participation in the study will be conducted.
The primary efficacy outcome will be change from baseline to the end of the study in behavioral scores measured with the Neuropsychiatric Inventory-Nursing Home (NPI-NH) in its Spanish-validated version. As a secondary efficacy variable, changes from baseline to the end of the study in Cohen-Mansfield Agitation Inventory (CMAI) and Cornell Scale for Depression in Dementia (CSDD) scores will be used.
In addition, an assessment of cognitive functions, functional capacity and quality of life of patients will be carried out using the MiniMental State Examination (MMSE), the Severe MiniMental State Examination (S-MMSE), the Severe Impairment Battery (SIB), the Verbal Semantic and Phonological Fluency tests, the Bedford Alzheimer Nursing-Severity Scale (BANS-S), the Barthell Index (BI) and the Quality of Life in Late-stage Dementia (QUALID).
Finally, assessment of the impact of BPSD on the caregiver will be carried out using the caregiver occupational disruption subscale of the NPI-NH.
José María García-Alberca. Psychiatrist. Principal investigator
María Dolores de la Rosa Gámiz. Neuropsychologist.
Pablo Lara Muñoz. Cognitive neurophysiologist.
Paloma Solo de Zaldívar del Amo. Neuropsychologist.
Esther Gris Ferrer. Neuropsychologist.
Estela Oltra Pérez. Neuropsychologist.
María Ledesma Moreno. Neuropsychologist
Miguel Ángel Barbancho Fernández. Family physician.
Encarnación Blanco Reina. Clinical pharmacologist.
Ana Sánchez Fernández. Geriatrician.
Natalia García Casares. Neurologist.
Olga Ocejo. Neuropsychologist.