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Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Pittsburgh
National Institute on Aging (NIA)
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00178568
  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 I

MedlinePlus related topics: Caregivers Dementia Sleep Disorders
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Cross-Sectional
Official Title: AgeWise Project 2: Reducing Stress and Sleep Disturbances in Caregivers of Patients With Progressive Dementia

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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:
    Behavioral: Stress Management and Healthy Sleep Practices
    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:

  1. the impact of stress-related sleep disruptions on health in older adults, and
  2. 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

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

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

Keywords provided by University of Pittsburgh:
Sleep disturbances
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
Sleep disorder C10.886.425.800.800

Study placed in the following topic categories:
Alzheimer Disease
Sleep Disorders
Dyssomnias
Stress
Central Nervous System Diseases
Brain Diseases
Cognition Disorders
 Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Parkinson Disease
Mental Disorders
Neurologic Manifestations
Dementia
Delirium

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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