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Alzheimer Patients and the Snoezelen Program

Primary Purpose

Dementia

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Snoezelen Room
Snoezelen Room
Control
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rideaucrest Home

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

1

2

3

Arm Description

Subject receives Snoezelen sessions once per week.

Subject receives Snoezelen sessions three times per week.

Subject receives no sessions per week.

Outcomes

Primary Outcome Measures

To evaluate improvement of the residents who are given Snoezelen sessions.

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
December 14, 2015
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00548951
Brief Title
Alzheimer Patients and the Snoezelen Program
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Subject receives Snoezelen sessions once per week.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Subject receives Snoezelen sessions three times per week.
Arm Title
3
Arm Type
Other
Arm Description
Subject receives no sessions per week.
Intervention Type
Other
Intervention Name(s)
Snoezelen Room
Intervention Description
Session in a Snoezelen room once per week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Snoezelen Room
Intervention Description
Session in a Snoezelen room three times per week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Receive no sessions in a Snoezelen Room.
Primary Outcome Measure Information:
Title
To evaluate improvement of the residents who are given Snoezelen sessions.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roumen V. Milev, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rideaucrest Home
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7K 3H6
Country
Canada

12. IPD Sharing Statement

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Alzheimer Patients and the Snoezelen Program

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