Trial record 11 of 1571 for: "Sleep Disorders"

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Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by University of Pittsburgh.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

National Institute on Aging (NIA)

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00178568

First received: September 13, 2005

Last updated: June 9, 2008

Last verified: June 2008

History of Changes

Purpose

People under stress, such as those caring for an ill family member, often have trouble with their sleep. The aim of this study is to see if reducing stress and changing a caregiver's sleep and wake patterns will improve his/her sleep. The investigators also will see whether improvements in sleep result in improved mood, health, and general functioning.

Condition	Intervention	Phase
Sleep Disorders	Behavioral: Stress Management and Healthy Sleep Practices	Phase 1

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	AgeWise Project 2: Reducing Stress and Sleep Disturbances in Caregivers of Patients With Progressive Dementia

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease

MedlinePlus related topics: Caregivers Dementia Sleep Disorders

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: Samples Without DNA

Saliva collected on cotton rolls and frozen by participant. Kept frozen until shipped for assay.

Estimated Enrollment:	60
Study Start Date:	February 2003
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Eight weekly sessions of 1 hour each reviewing stress management techniques and tips for improving sleep.

Detailed Description:

The general aim of this study is to characterize stress-related sleep disturbances in spousal caregivers of patients with progressive dementia and to test the efficacy of an intervention designed to reduce stress and sleep disturbances. We will compare the efficacy of a Stress Management Plus Health Sleep Practices (SM+HSP) intervention to an attention-only control condition in spousal caregivers of patients with progressive dementia.

Specific Aims for this study are:

Aim 1: To characterize stress-related sleep disruptions in spousal caregivers of patients with progressive dementia.

Aim 2: To test the short-term efficacy of a Stress Management Plus Healthy Sleep Practices (SM+HSP) intervention versus an attention-only control for improving sleep and health outcomes in caregivers of patients with progressive dementia.

Aim 3: To test the durability of the SM+HSP intervention among spousal caregivers of patients with progressive dementia.

Aim 4: To characterize:

the impact of stress-related sleep disruptions on health in older adults, and
the effects of sleep interventions on health and functioning.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Males and females over the age of 60 who are primary caregiver for spouse/partner diagnosed with progressive dementia.

Criteria

Inclusion Criteria:

Ages 60 or older
Spousal caregivers of patients with progressive dementia
Patients have a diagnosis of possible or probable Alzheimer's disease or other progressive dementia
Affirm that it is a physical and emotional strain to care for spouse
Pittsburgh Sleep Quality Index score of 5 or above or a polysomnographically determined sleep efficiency of 90% or worse.

Exclusion Criteria:

Psychotic disorder or substance abuse disorder
Apnea-hypopnea index of greater than 30
Score of less than 24 on Mini-Mental State Exam

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178568

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

National Institute on Aging (NIA)

Investigators

Principal Investigator:	Martica Hall, Ph.D.	University of Pittsburgh
Study Director:	Lynn Martire, Ph.D.	University of Pittsburgh
Study Director:	Greg Seigel, Ph.D.	University of Pittsburgh
Study Director:	Richard Schulz, Ph.D.	University of Pittsburgh
Study Director:	Charles F. Reynolds, III, M.D.	University of Pittsburgh

More Information

Additional Information:

University of Pittsburgh Institute on Aging This link exits the ClinicalTrials.gov site

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Responsible Party:	Dr. Martica Hall, University of Pittsburgh Medical Center - WPIC
ClinicalTrials.gov Identifier:	NCT00178568 History of Changes
Other Study ID Numbers:	021117, 1 P01 AG20677-01
Study First Received:	September 13, 2005
Last Updated:	June 9, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Sleep disturbances
Sleep disorder C10.886.425.800.800
Caregiving
Spousal
Progressive dementia
Stress
Health outcomes

Intervention
Affective self-management
Caregivers M01.526.485.200
Spouses F01.829.263.500.660
Alzheimer's disease C10.574.945.249
Parkinson's disease C10.574.812

Additional relevant MeSH terms:

Sleep Disorders
Parasomnias
Dementia
Dyssomnias
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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