- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548951
Alzheimer Patients and the Snoezelen Program
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
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Kingston, Ontario, Canada, K7K 3H6
- Rideaucrest Home
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Subject receives Snoezelen sessions once per week.
|
Session in a Snoezelen room once per week for 12 weeks
Session in a Snoezelen room three times per week for 12 weeks
|
|
Active Comparator: 2
Subject receives Snoezelen sessions three times per week.
|
Session in a Snoezelen room once per week for 12 weeks
Session in a Snoezelen room three times per week for 12 weeks
|
|
Other: 3
Subject receives no sessions per week.
|
Receive no sessions in a Snoezelen Room.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate improvement of the residents who are given Snoezelen sessions.
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roumen V. Milev, MD, Queen's University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSIY-205-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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