NCT00548951

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

September 12, 2005

Last Update Submit

December 14, 2015

Conditions

Dementia

Keywords

Dementia

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Subject receives Snoezelen sessions once per week.

Other: Snoezelen Room

2

ACTIVE COMPARATOR

Subject receives Snoezelen sessions three times per week.

Other: Snoezelen Room

3

OTHER

Subject receives no sessions per week.

Other: Control

Interventions

Snoezelen RoomOTHER

Session in a Snoezelen room once per week for 12 weeks

1
ControlOTHER

Receive no sessions in a Snoezelen Room.

3

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rideaucrest Home

Kingston, Ontario, K7K 3H6, Canada

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Roumen V. Milev, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

October 24, 2007

Study Start

September 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

CA(1)