MedDataX Logo

Alzheimer Patients and the Snoezelen Program

NCT ID: NCT00548951

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Subject receives Snoezelen sessions once per week.

Group Type ACTIVE_COMPARATOR

Snoezelen Room

Intervention Type OTHER

Session in a Snoezelen room once per week for 12 weeks

2

Subject receives Snoezelen sessions three times per week.

Group Type ACTIVE_COMPARATOR

Snoezelen Room

Intervention Type OTHER

Session in a Snoezelen room three times per week for 12 weeks

3

Subject receives no sessions per week.

Group Type OTHER

Control

Intervention Type OTHER

Receive no sessions in a Snoezelen Room.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Snoezelen Room

Session in a Snoezelen room once per week for 12 weeks

Intervention Type OTHER

Snoezelen Room

Session in a Snoezelen room three times per week for 12 weeks

Intervention Type OTHER

Control

Receive no sessions in a Snoezelen Room.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queen's University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Roumen Milev

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roumen V. Milev, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rideaucrest Home

Kingston, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSIY-205-05

Identifier Type: -

Identifier Source: org_study_id