NCT00013182

Brief Summary

Sleep-activity rhythm disturbance is a prevalent, disabling symptom in cognitively-impaired (CI) elders. Their nocturnal sleep is light and inefficient with frequent awakenings. Multiple short daytime napping episodes interfere with daytime activity and functioning. Daytime disruptive behaviors, such as pacing, hitting, and cursing are related significantly to sleep-activity rhythm disturbance. Medical treatment for sleep and behavior disturbances with benzodiazepines or antipsychotic medications has proven minimally effective and has serious side effects such as impairments in cognition, memory, coordination, and balance, tolerance and severe rebound insomnia, and tardive dyskinesia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
Last Updated

April 7, 2015

Status Verified

February 1, 2007

First QC Date

March 14, 2001

Last Update Submit

April 6, 2015

Conditions

Alzheimer's DiseaseSleep Disorders

Study Arms (1)

Arm 1

OTHER
Behavioral: social activity

Interventions

social activityBEHAVIORAL
Arm 1

Eligibility Criteria

Age55 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have been a resident in the nursing home for at least two weeks, must be at least 55 years old, have a diagnosis of dementia, a Mini-Mental State Examination Score of \<24, sleep less than 85% of the night, and nap at least 30 minutes during the day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, 72114-1706, United States

Location

Related Publications (5)

  • Richards KC, Beck C, Shue VM, O'Sullivan PS. Demographic and sleep characteristics in cognitively impaired nursing home residents with and without severe sleep/wake pattern inefficiency. Issues Ment Health Nurs. 2005 Aug-Sep;26(7):751-69. doi: 10.1080/01612840591008339.

    PMID: 16126650RESULT

  • Richards KC, Beck C, O'Sullivan PS, Shue VM. Effect of individualized social activity on sleep in nursing home residents with dementia. J Am Geriatr Soc. 2005 Sep;53(9):1510-7. doi: 10.1111/j.1532-5415.2005.53460.x.

    PMID: 16137280RESULT

  • Richards KC, Sullivan SC, Phillips RL, Beck CK, Overton-McCoy AL. The effect of individualized activities on the sleep of nursing home residents who are cognitively impaired: a pilot study. J Gerontol Nurs. 2001 Sep;27(9):30-7. doi: 10.3928/0098-9134-20010901-07.

    PMID: 11820554RESULT

  • Kolanowski AM, Richards KC, Sullivan SC. Derivation of an intervention for need-driven behavior. Activity preferences of persons with dementia. J Gerontol Nurs. 2002 Oct;28(10):12-5. doi: 10.3928/0098-9134-20021001-06. No abstract available.

    PMID: 12382454RESULT

  • Richards KC, Lambert C, Beck CK. Deriving interventions for challenging behaviors from the need-driven dementia-compromised behavior model. Alzheimer's care today. 2000 Oct 15; 1(4):62-76.

    RESULT

MeSH Terms

Conditions

Alzheimer DiseaseSleep Wake Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathleen C. Richards, PhD RN

    Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Completion

June 1, 2001

Last Updated

April 7, 2015

Record last verified: 2007-02

Locations

US(1)