Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia (SMT)

12 giugno 2026 aggiornato da: University of Primorska

Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia

This randomized, controlled, longitudinal clinical trial investigates the effects of Snoezelen Multisensory Therapy (SMT) as an adjunct to standard therapy (ST) in older adults with dementia. Sixty participants with mild to moderate cognitive impairment and behavioral and psychological symptoms of dementia (BPSD) will be recruited from the Center for Older Adults Lucija (Slovenia). Participants will be randomized into two groups: control (ST) and experimental (ST + SMT). SMT will be administered 3 times per week for 12 weeks. Primary outcomes include changes in agitation (CMAI), depression (CSDD), anxiety (HADS), physiological indicators (heart rate, HR variability, SpO2, skin conductance, salivary cortisol), and frequency of psychiatric medication use. Subjective well-being will also be tracked before and after each session.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Dementia is a growing public health concern, with high rates of behavioral and psychological symptoms (BPSD), such as depression, agitation, and anxiety. Non-pharmacological therapies like Snoezelen Multisensory Therapy (SMT) are increasingly explored as safe and effective alternatives or complements to standard therapy (ST).

This randomized controlled clinical trial will evaluate the acute and chronic effects of SMT in 60 patients with dementia at the Center for Older Adults Lucija, Slovenia. Participants will be stratified by medication use and cognitive status and randomly assigned to either an experimental group receiving SMT + ST, or a control group receiving ST alone. SMT consists of 30-minute sessions in a multisensory room equipped according to Snoezelen® guidelines. Sessions will be personalized and monitored, including physiological measurements before and after therapy.

Primary outcomes will include changes in BPSD measured by the Cornell Scale for Depression in Dementia (CSDD), the Hospital Anxiety and Depression Scale (HADS), and the Cohen-Mansfield Agitation Inventory (CMAI). Physiological indicators such as heart rate (HR), heart rate variability (HRV), oxygen saturation (SpO2), skin conductance, and salivary cortisol will be collected before and after the 1st and 36th sessions. Medication use (PRN) will be tracked every two weeks.

The study includes translation and validation of BPSD assessment tools into Slovenian. Results are expected to contribute valuable data to the field of dementia care and support broader implementation of SMT in geriatric settings. This study was registered retrospectively on ClinicalTrials.gov after study completion.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Slovenia
      • Portorož, Slovenia, 6320
        • Center for Older Adults Lucija

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

Age 65 years or older

Diagnosed dementia (any subtype)

Montreal Cognitive Assessment (MoCA) score between 10-25

Katz Performance Status Score (KPSS) between 10-24

Behavioral and psychological symptoms of dementia (BPSD), indicated by at least one of the following:

Cornell Scale for Depression in Dementia (CSDD) score >10

Hospital Anxiety and Depression Scale (HADS) score >8

Cohen-Mansfield Agitation Inventory (CMAI) showing moderate or severe symptoms

Ability to follow basic instructions and communicate needs

Written informed consent obtained from the participant or their legal representative

Exclusion Criteria:

  • Acute psychiatric illness or unstable somatic condition

Severe visual or hearing impairments

Inability to communicate in Slovenian

Concurrent participation in psychotherapy or physiotherapy

Diagnosis of epilepsy

Changes to psychiatric medication within 4 weeks prior to study start

Any other condition that, in the opinion of the research team, would interfere with participation or data collectio

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SMT + Standard Therapy
Participants in this group will receive standard therapy routinely provided at the care center in addition to Snoezelen Multisensory Therapy (SMT). SMT will be delivered individually in a Snoezelen-designed multisensory room for 30 minutes, three times per week, over a 12-week period. Sessions will be tailored to each participant's sensory profile and preferences.
Comportamentale: Snoezelen Multisensory Therapy
A non-pharmacological, individualized sensory stimulation therapy delivered in a Snoezelen-designed multisensory environment. Sessions include visual, auditory, tactile, and olfactory stimuli tailored to the participant's sensory profile and preferences. The intervention is delivered individually for 30 minutes, three times per week, over a 12-week period and is intended to reduce behavioral and psychological symptoms of dementia and improve well-being.
Altri nomi:
  • SMT
  • Snoezelen
  • MSS
  • Multisensory stimulation
Comportamentale: Standard Therapy
Standard therapy refers to routine care provided in the residential care setting and includes cognitive stimulation activities, group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. These interventions are delivered by trained staff as part of the regular care program. No Snoezelen Multisensory Therapy or other multisensory stimulation interventions are provided as part of standard therapy.
Altri nomi:
  • ST
  • Terapia occupazionale
  • Allenamento cognitivo
  • Cura di routine
  • Group Social Engagement
Comparatore attivo: Standard Therapy Only
Participants in this group will receive standard therapy routinely provided at the care center, including cognitive stimulation activities (e.g., memory games, orientation exercises, attention and problem-solving tasks), group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. No Snoezelen Multisensory Therapy (SMT) will be provided.
Comportamentale: Standard Therapy
Standard therapy refers to routine care provided in the residential care setting and includes cognitive stimulation activities, group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. These interventions are delivered by trained staff as part of the regular care program. No Snoezelen Multisensory Therapy or other multisensory stimulation interventions are provided as part of standard therapy.
Altri nomi:
  • ST
  • Terapia occupazionale
  • Allenamento cognitivo
  • Cura di routine
  • Group Social Engagement

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
Lasso di tempo: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
The Cohen-Mansfield Agitation Inventory (CMAI) is used to measure the frequency of agitated behaviors in elderly participants with dementia. Scores range from 29 to 203, with higher scores indicating more frequent agitation.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD)
Lasso di tempo: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
The CSDD assesses signs of depression in individuals with dementia. Scores range from 0 to 38, with higher scores indicating more severe depression.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in anxiety level (HADS-Anxiety Subscale)
Lasso di tempo: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
HADS-A is a validated subscale that measures anxiety in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in heart rate
Lasso di tempo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in subjective well-being using a self-reported analog scale
Lasso di tempo: Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
Participants report their mood, comfort, and overall well-being on a self-reported visual analog scale ranging from 0 to 5 before and after each SMT session.
Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
Change in heart rate variability (HRV)
Lasso di tempo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in skin conductance
Lasso di tempo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in oxygen saturation (SpO₂)
Lasso di tempo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in salivary cortisol concentration
Lasso di tempo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Primorska

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2023

Completamento primario (Effettivo)

1 agosto 2024

Completamento dello studio (Effettivo)

1 agosto 2024

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UPrimosrka
  • 0120-104/2020/6 (Altro identificatore: Slovenian National Medical Ethics Committee)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as the dataset contains sensitive information from vulnerable populations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Snoezelen Multisensory Therapy

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Luxembourg

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi