DementiaSMTNCT07657208
Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia
A study testing Snoezelen Multisensory Therapy and Standard Therapy in people with Dementia, run by University of Primorska at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Snoezelen Multisensory Therapy and Standard Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Aug 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Diagnosed dementia (any subtype)
- Montreal Cognitive Assessment (MoCA) score between 10-25
- Mini Mental State Examination (MMSE) 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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-three 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.
Read the detailed description
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 63 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.
- Conditions
- Dementia
- Being tested
- Snoezelen Multisensory Therapy, Standard Therapy
- Keywords
- Dementia, Behavioral and Psychological Symptoms of Dementia, BPSD, Snoezelen, Multisensory Therapy, SMT, Non-pharmacological therapy, Heart rate variability, Salivary cortisol, Elderly, Cognitive decline, Agitation, Depression, Physiological markers, AD
- Medical subject headings
- Dementia, Behavior, Cognitive Dysfunction, Psychomotor Agitation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snoezelen Multisensory TherapyBehavioural
Also called SMT, Multisensory stimulation, MSS, Snoezelen
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.
Standard TherapyBehavioural
Also called ST, Routine care, Cognitive Training, Occupational 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.
| Study group | Role | What they receive |
|---|---|---|
| SMT + Standard Therapy | Experimental | 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. Receives: Behavioral: Snoezelen Multisensory Therapy; Behavioral: Standard Therapy |
| Standard Therapy Only | Active comparator | 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. Receives: Behavioral: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
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.
Measured: 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)
The CSDD assesses signs of depression in individuals with dementia. Scores range from 0 to 38, with higher scores indicating more severe depression.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in anxiety and depression level measured with the Hospital Anxiety and Depression Scale (HADS)
HADS is a validated subscale that measures anxiety and depression in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety.
Measured: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in heart rate
Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response.
Measured: 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
Participants report their mood, comfort, and overall well-being on a self-reported visual analog scale ranging from 1 to 5 before and after each SMT session.
Measured: Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
Change in heart rate variability (HRV)
Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy.
Measured: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in skin conductance
Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response
Measured: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in oxygen saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy.
Measured: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in salivary cortisol concentration
Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity.
Measured: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel arms. The intervention arm will receive Snoezelen Multisensory Therapy (SMT) in addition to standard therapy.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657208
- Sponsor's protocol ID
- UPrimorska_DSN
- Other IDs
- 0120-104/2020/6
- Acronym
- SMT
- Status last verified
- Aug 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as the dataset contains sensitive information from vulnerable populations.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT07657208
- Acronym / sponsor ID
- SMT / UPrimorska_DSN
- Conditions
- Dementia
- Keywords
- Dementia, Behavioral and Psychological Symptoms of Dementia, BPSD, Snoezelen, Multisensory Therapy, SMT, Non-pharmacological therapy, Heart rate variability, Salivary cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-three 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.
Detailed description
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 63 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel arms. The intervention arm will receive Snoezelen Multisensory Therapy (SMT) in addition to standard therapy.
| Arm | Type | Receives |
|---|---|---|
| SMT + Standard Therapy | Experimental | Behavioral: Snoezelen Multisensory Therapy, Behavioral: Standard TherapyParticipants 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. |
| Standard Therapy Only | Active comparator | Behavioral: Standard TherapyParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Age 65 years or older
- Diagnosed dementia (any subtype)
- Montreal Cognitive Assessment (MoCA) score between 10-25
- Mini Mental State Examination (MMSE) between 10-24
- Behavioral and psychological symptoms of dementia (BPSD), indicated by at least one of the following:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snoezelen Multisensory TherapyAlso: SMT, Multisensory stimulation, MSS, SnoezelenA 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. | Behavioural | SMT + Standard Therapy |
| Standard TherapyAlso: ST, Routine care, Cognitive Training, Occupational TherapyStandard 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. | Behavioural | SMT + Standard Therapy, Standard Therapy Only |
Primary outcome
Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: 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.
Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD)
Time frame: 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.
Change in anxiety and depression level measured with the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
HADS is a validated subscale that measures anxiety and depression in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety.
Change in heart rate
Time frame: 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.
Change in subjective well-being using a self-reported analog scale
Time frame: 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 1 to 5 before and after each SMT session.
Change in heart rate variability (HRV)
Time frame: 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.
Change in skin conductance
Time frame: 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
Change in oxygen saturation (SpO₂)
Time frame: 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.
Change in salivary cortisol concentration
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as the dataset contains sensitive information from vulnerable populations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snoezelen Multisensory Therapy and Standard Therapy in people with Dementia, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI) (time frame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.