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

NCT05706792 | Completed

• 1 other identifier: NSC-DEMEN Study
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Dementia

Keywords

Dementia; Behavioral symptoms of dementia; Dementia care

Outcome Measures

Primary Outcomes (1)

• Change in behavioral and psychological symptoms of dementia measured by the Neuropsychiatric Inventory Nursing Home.

  The Neuropsychiatric Inventory Nursing Home is an instrument to be used by the nursing staff to evaluate neuropsychiatric symptoms in people with dementia in the nursing home setting. The NPI-NH is composed of 12 domains that rate the most frequent behavioral and psychological symptoms of dementia. If a symptom was present during the previous month, frequency (ranging from 1 to 4), severity (ranging from 1 to 3) and composite scores (frequency x severity, ranging from 1 to 144) were obtained. Higher scores mean greater severity of behavioural symptoms.

  Baseline, 6 week, 12 week, 14 week.

Secondary Outcomes (2)

• Change in agitation measured by the Cohen-Mansfield Agitation Inventory.

  Baseline, 6 week, 12 week, 14 week.

• Change in depression measured by the Cornell Scale for Depression in Dementia.

  Baseline, 6 week, 12 week, 14 week.

Other Outcomes (4)

• Change in cognitive function measured by the Severe Mini Mental State Examination.

  Baseline, 14 week.

• Change in functional status measured by the Bedford Alzheimer Nursing-Severity Scale. scores at 14 weeks.

  Baseline, 14 week.

• Change in quality of life measured by the Quality of Life in Late-stage Dementia.

  Baseline, 14 week.

Study Arms (2)

Nordic Sensi Chair

EXPERIMENTAL

Participants received three times a week one session per day of 20 minutes in the Relax for deep relaxation program of the Nordic Sensi Chair.

Device: Nordic Sensi Chair

Standard of care

NO INTERVENTION

Participants did not participate in the Nordic Sensi Chair sessions, but received, at the same time and duration, the care and activities that were part of the daily routines of the center, including group sessions of cognitive stimulation, training in activities of daily living or communication training.

Interventions

Nordic Sensi Chair DEVICE

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.

Nordic Sensi Chair

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with a diagnosis of dementia according to the criteria of the eleventh edition of the International Classification of Diseases of the World Health Organization (ICD-11).
• The patients will be clinically defined in stages 5 to 7 of the Reisberg Global Deterioration Scale (GDS).
• All selected patients should have data on physical examination, neurological and psychiatric examination, as well as neuropsychological evaluation in their clinical history.
• Written informed consent signed by the patient or his/her legal representative

You may not qualify if:

• Presence of focal neurological signs.
• Presence of focal vascular signs such as infarcts, microhemorrhages, hematomas, strokes, normal pressure hydrocephalus.
• Significant neurological history, such as brain trauma, brain tumors....
• Patients with epilepsy or inflammatory brain disease.
• Severe systemic diseases such as hypothyroidism or chronic renal failure.
• Substance abuse.
• Absence of a reliable informant.
• Absence of a complete medical history to assess study variables.

Sponsors & Collaborators

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

Study Sites (1)

Instituto Andaluz de Neurociencia

Málaga, 29012, Spain

Location

Related Publications (23)

• van der Linde RM, Dening T, Stephan BC, Prina AM, Evans E, Brayne C. Longitudinal course of behavioural and psychological symptoms of dementia: systematic review. Br J Psychiatry. 2016 Nov;209(5):366-377. doi: 10.1192/bjp.bp.114.148403. Epub 2016 Aug 4.

  PMID: 27491532 BACKGROUND

• Rocca P, Leotta D, Liffredo C, Mingrone C, Sigaudo M, Capellero B, Rocca G, Simoncini M, Pirfo E, Bogetto F. Neuropsychiatric symptoms underlying caregiver stress and insight in Alzheimer's disease. Dement Geriatr Cogn Disord. 2010;30(1):57-63. doi: 10.1159/000315513. Epub 2010 Aug 5.

  PMID: 20689284 BACKGROUND

• Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT. Determinants of quality of life in nursing home residents with dementia. Dement Geriatr Cogn Disord. 2010;29(3):189-97. doi: 10.1159/000280437. Epub 2010 Mar 6.

  PMID: 20215750 BACKGROUND

• Bessey LJ, Walaszek A. Management of Behavioral and Psychological Symptoms of Dementia. Curr Psychiatry Rep. 2019 Jul 1;21(8):66. doi: 10.1007/s11920-019-1049-5.

  PMID: 31264056 BACKGROUND

• Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.

  PMID: 32738937 BACKGROUND

• Seitz DP, Brisbin S, Herrmann N, Rapoport MJ, Wilson K, Gill SS, Rines J, Le Clair K, Conn D. Efficacy and feasibility of nonpharmacological interventions for neuropsychiatric symptoms of dementia in long term care: a systematic review. J Am Med Dir Assoc. 2012 Jul;13(6):503-506.e2. doi: 10.1016/j.jamda.2011.12.059. Epub 2012 Feb 17.

  PMID: 22342481 BACKGROUND

• Snyder M, Tseng Y, Brandt C, Croghan C, Hanson S, Constantine R, Kirby L. A glider swing intervention for people with dementia. Geriatr Nurs. 2001 Mar-Apr;22(2):86-90. doi: 10.1067/mgn.2001.115197.

  PMID: 11326215 BACKGROUND

• Zhang Y, Cai J, An L, Hui F, Ren T, Ma H, Zhao Q. Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis. Ageing Res Rev. 2017 May;35:1-11. doi: 10.1016/j.arr.2016.12.003. Epub 2016 Dec 23.

  PMID: 28025173 BACKGROUND

• Wood S, Cummings JL, Hsu MA, Barclay T, Wheatley MV, Yarema KT, Schnelle JF. The use of the neuropsychiatric inventory in nursing home residents. Characterization and measurement. Am J Geriatr Psychiatry. 2000 Winter;8(1):75-83. doi: 10.1097/00019442-200002000-00010.

  PMID: 10648298 BACKGROUND

• Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989 May;44(3):M77-84. doi: 10.1093/geronj/44.3.m77.

  PMID: 2715584 BACKGROUND

• Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

  PMID: 7183759 BACKGROUND

• Koder D, Hunt GE, Davison T. Staff's views on managing symptoms of dementia in nursing home residents. Nurs Older People. 2014 Nov;26(10):31-6. doi: 10.7748/nop.26.10.31.e638.

  PMID: 25430844 BACKGROUND

• Gruber-Baldini AL, Boustani M, Sloane PD, Zimmerman S. Behavioral symptoms in residential care/assisted living facilities: prevalence, risk factors, and medication management. J Am Geriatr Soc. 2004 Oct;52(10):1610-7. doi: 10.1111/j.1532-5415.2004.52451.x.

  PMID: 15450035 BACKGROUND

• Zucchella C, Sinforiani E, Tamburin S, Federico A, Mantovani E, Bernini S, Casale R, Bartolo M. The Multidisciplinary Approach to Alzheimer's Disease and Dementia. A Narrative Review of Non-Pharmacological Treatment. Front Neurol. 2018 Dec 13;9:1058. doi: 10.3389/fneur.2018.01058. eCollection 2018.

  PMID: 30619031 BACKGROUND

• Krutter S, Schaffler-Schaden D, Essl-Maurer R, Wurm L, Seymer A, Kriechmayr C, Mann E, Osterbrink J, Flamm M. Comparing perspectives of family caregivers and healthcare professionals regarding caregiver burden in dementia care: results of a mixed methods study in a rural setting. Age Ageing. 2020 Feb 27;49(2):199-207. doi: 10.1093/ageing/afz165.

  PMID: 31875879 BACKGROUND

• Sprangers S, Dijkstra K, Romijn-Luijten A. Communication skills training in a nursing home: effects of a brief intervention on residents and nursing aides. Clin Interv Aging. 2015 Jan 20;10:311-9. doi: 10.2147/CIA.S73053. eCollection 2015.

  PMID: 25653513 BACKGROUND

• Burks HB, des Bordes JKA, Chadha R, Holmes HM, Rianon NJ. Quality of Life Assessment in Older Adults with Dementia: A Systematic Review. Dement Geriatr Cogn Disord. 2021;50(2):103-110. doi: 10.1159/000515317. Epub 2021 Jun 24.

  PMID: 34167127 BACKGROUND

• Kim SK, Park M. Effectiveness of person-centered care on people with dementia: a systematic review and meta-analysis. Clin Interv Aging. 2017 Feb 17;12:381-397. doi: 10.2147/CIA.S117637. eCollection 2017.

  PMID: 28255234 BACKGROUND

• Lee KH, Lee JY, Kim B. Person-Centered Care in Persons Living With Dementia: A Systematic Review and Meta-analysis. Gerontologist. 2022 Apr 20;62(4):e253-e264. doi: 10.1093/geront/gnaa207.

  PMID: 33326573 BACKGROUND

• Harrell LE, Marson D, Chatterjee A, Parrish JA. The Severe Mini-Mental State Examination: a new neuropsychologic instrument for the bedside assessment of severely impaired patients with Alzheimer disease. Alzheimer Dis Assoc Disord. 2000 Jul-Sep;14(3):168-75. doi: 10.1097/00002093-200007000-00008.

  PMID: 10994658 BACKGROUND

• Volicer L, Hurley AC, Lathi DC, Kowall NW. Measurement of severity in advanced Alzheimer's disease. J Gerontol. 1994 Sep;49(5):M223-6. doi: 10.1093/geronj/49.5.m223.

  PMID: 8056941 BACKGROUND

• Weiner MF, Martin-Cook K, Svetlik DA, Saine K, Foster B, Fontaine CS. The quality of life in late-stage dementia (QUALID) scale. J Am Med Dir Assoc. 2000 May-Jun;1(3):114-6.

  PMID: 12818023 BACKGROUND

• Garcia-Alberca JM, de la Rosa MD, Solo de Zaldivar P, Ledesma M, Oltra E, Gris E, Ocejo O, Torrecilla J, Zafra C, Sanchez-Fernandez A, Mancilla T, Lopez-Romero M, Jerez R, Santana N, Lara JP, Barbancho MA, Blanco-Reina E. Effect of Nordic Sensi(R) Chair on Behavioral and Psychological Symptoms of Dementia in Nursing Homes Residents: A Randomized Controlled Trial. J Alzheimers Dis. 2023;96(4):1609-1622. doi: 10.3233/JAD-230391.

  PMID: 38007648 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jose Maria Garcia-Alberca, MD, PhD

  Instituto Andaluz de Neurociencia (IANEC), 17 Álamos Street, 29012 Málaga, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Instituto Andaluz de Neurociencia (IANEC), 17 Álamos Street, 29012 Málaga, Spain

Model Details: This was a 16-week randomized, parallel, single-blind, controlled, clinical trial. After assessments for eligibility patients were randomly assigned to two groups of equal size: a treatment group that received three times a week one session per day of 20 minutes in the NSC Relax for relaxation program and a control group that did not participate in the activity mentioned for the treatment group, but received, at the same time and duration, the care and activities that were part of the daily routines of the center. The 16-week study extension included a first pre-treatment period of 2 weeks' duration prior to the start of the intervention to establish the baseline, followed by a second 12-week treatment period with the use of the NSC and, finally, a third post-treatment period conducted 2-week after completion of the intervention.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: May 20, 2022
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and datasets used and/or analyzed during this study will be available 6 months after the publication of the results for 5 years
• Access Criteria: At the present time, we do not have a public repository URL with a direct link to our data because we are still working on them. However, data supporting the findings of this study are available from the principal investigator. Data may be shared with researchers and institutions related to the research topic. We may share the study protocol, the informed consent form, and the data. The latter, will be available once we have analyzed the database. The access mechanism, for the moment, is through the principal investigator upon reasonable request.

Locations

ES (1)