DementiaPhase 1NCT00548951
Alzheimer Patients and the Snoezelen Program
A Phase 1 study testing Snoezelen Room in people with Dementia, run by Queen's University at 1 site in Canada.
Trial summary
To determine the connection between Social Withdrawal and Sensory Deprivation in elderly clients with Alzheimer's Type Dementia (i.e. how providing sensory stimulation might reduce social withdrawal). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Snoezelen Room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Dec 2006
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Residents living at Rideaucrest Home (Long Term Care Facility in Kingston, Ontario);
- Residents having a Mini Mental State Exam with a score of 15 to 27 reflecting mild to moderate dementia;
- Male or female over 65 years of age;
- Resident who are able to leave the terrace;
- Resident who are not actively participating in Life Enrichment Programs;
- Able to provide informed written and signed consent by resident or substitute decision maker.
Who cannot join
- Suffering from severe life threatening illness with a reasonable expectation of death within the next six month;
- Severe mental disorder in the opinion of the investigator (i.e. bipolar, schizophrenia);
- No recent change in medication(s) during the past four weeks prior to the project;
- Other non-Alzheimer-Type Dementia;
- Residents who suffer from Epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Connection Between Sensory Deprivation and Social Withdrawal in Clients of a Long Term Care Facility Living With Alzheimer's Disease and the Effects of a Snoezelen Program.
To determine the connection between Social Withdrawal and Sensory Deprivation in elderly clients with Alzheimer's Type Dementia (i.e. how providing sensory stimulation might reduce social withdrawal).
Read the detailed description
The Snoezelen concept or program was originally thought up in Holland and comes from two Dutch words meaning to "sniff and doze". It was first introduced in the Netherlands in the 1970's. The first room was introduced in Snoezelen examines how a group of people react to an area that is private, relaxed and one that they trust. This program will bring out one's sense of taste, touch, smell, sight and hearing just by being in a specially designed room. Trust and relaxation will be looked at by those people with developmental disabilities (those that learn at a slower rate). Snoezelen originated with the belief that everyone needs nerve pulses (senses).
Inside a Snoezelen room you will find, dimmed lights, a relaxed atmosphere and pleasant surroundings, soothing sounds, intriguing aromas, tasty puddings, candies, interesting light effects (fiber optic light spray), comfortable seating, opportunities for interaction and engagement, sense of control over environment, tactile objects (awareness box), bubble tube, solar projector wheel, water fountain, massage pillow, massage tube, tranquility and solitude. The Snoezelen room is an environment in which the primary senses (see, hear, taste, touch) are stimulated all to create an environment that is both relaxing and stimulating. The benefits of Snoezelen change per person but may include some of the following:
- Increased resident and caregiver communication
- Increased awareness and understanding of the environment
The Snoezelen idea: client-controlled, safe comfortable atmosphere and freedom from pressure.
Sensory Deprivation (loss) The average person touches 300 different surfaces every 30 minutes. The average person with a profound disability will likely touch 1-5 surfaces in the same time frame.
- Conditions
- Dementia
- Being tested
- Snoezelen Room, Control
- Keywords
- Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snoezelen RoomOther
Session in a Snoezelen room once per week for 12 weeks
Snoezelen RoomOther
Session in a Snoezelen room three times per week for 12 weeks
ControlOther
Receive no sessions in a Snoezelen Room.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subject receives Snoezelen sessions once per week. Receives: Other: Snoezelen Room |
| 2 | Active comparator | Subject receives Snoezelen sessions three times per week. Receives: Other: Snoezelen Room |
| 3 | Other | Subject receives no sessions per week. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate improvement of the residents who are given Snoezelen sessions.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startSep 2005
- Primary completionDec 2006
- Study completionDec 2006
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen V. Milev, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548951
- Sponsor's protocol ID
- PSIY-205-05
- Status last verified
- Dec 2015
- First submitted
- 12 Sep 2005
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Connection Between Sensory Deprivation and Social Withdrawal in Clients of a Long Term Care Facility Living With Alzheimer's Disease and the Effects of a Snoezelen Program.
- ClinicalTrials.gov ID
- NCT00548951
- Acronym / sponsor ID
- PSIY-205-05
- Conditions
- Dementia
- Keywords
- Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 24 Oct 2007 (estimated)
- 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.
To determine the connection between Social Withdrawal and Sensory Deprivation in elderly clients with Alzheimer's Type Dementia (i.e. how providing sensory stimulation might reduce social withdrawal).
Detailed description
The Snoezelen concept or program was originally thought up in Holland and comes from two Dutch words meaning to "sniff and doze". It was first introduced in the Netherlands in the 1970's. The first room was introduced in Snoezelen examines how a group of people react to an area that is private, relaxed and one that they trust. This program will bring out one's sense of taste, touch, smell, sight and hearing just by being in a specially designed room. Trust and relaxation will be looked at by those people with developmental disabilities (those that learn at a slower rate). Snoezelen originated with the belief that everyone needs nerve pulses (senses).
Inside a Snoezelen room you will find, dimmed lights, a relaxed atmosphere and pleasant surroundings, soothing sounds, intriguing aromas, tasty puddings, candies, interesting light effects (fiber optic light spray), comfortable seating, opportunities for interaction and engagement, sense of control over environment, tactile objects (awareness box), bubble tube, solar projector wheel, water fountain, massage pillow, massage tube, tranquility and solitude. The Snoezelen room is an environment in which the primary senses (see, hear, taste, touch) are stimulated all to create an environment that is both relaxing and stimulating. The benefits of Snoezelen change per person but may include some of the following:
- Increased resident and caregiver communication
- Increased awareness and understanding of the environment
The Snoezelen idea: client-controlled, safe comfortable atmosphere and freedom from pressure.
Sensory Deprivation (loss) The average person touches 300 different surfaces every 30 minutes. The average person with a profound disability will likely touch 1-5 surfaces in the same time frame.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Snoezelen RoomSubject receives Snoezelen sessions once per week. |
| 2 | Active comparator | Other: Snoezelen RoomSubject receives Snoezelen sessions three times per week. |
| 3 | Other | Other: ControlSubject receives no sessions per week. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Residents living at Rideaucrest Home (Long Term Care Facility in Kingston, Ontario);
- Residents having a Mini Mental State Exam with a score of 15 to 27 reflecting mild to moderate dementia;
- Male or female over 65 years of age;
- Resident who are able to leave the terrace;
- Resident who are not actively participating in Life Enrichment Programs;
Key exclusion criteria (5 listed)
- Suffering from severe life threatening illness with a reasonable expectation of death within the next six month;
- Severe mental disorder in the opinion of the investigator (i.e. bipolar, schizophrenia);
- No recent change in medication(s) during the past four weeks prior to the project;
- Other non-Alzheimer-Type Dementia;
- Residents who suffer from 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 RoomSession in a Snoezelen room once per week for 12 weeks | Other | 1 |
| Snoezelen RoomSession in a Snoezelen room three times per week for 12 weeks | Other | 2 |
| ControlReceive no sessions in a Snoezelen Room. | Other | 3 |
Primary outcome
To evaluate improvement of the residents who are given Snoezelen sessions.
Time frame: 12 weeks
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 16 Dec 2015.
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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.
Roumen V. Milev, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Snoezelen Room in people with Dementia, run by Queen's University at 1 site in Canada.
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 6 inclusion and 5 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 16 Dec 2015. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate improvement of the residents who are given Snoezelen sessions. (time frame: 12 weeks). 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 16 Dec 2015; AzTrials last refreshed its copy on 1 Nov 2026.