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Sleep DisordersNCT00178568

Reducing Caregiver Stress and Sleep Disturbances in Patients With Progressive Dementia

An observational study of Sleep Disorders, run by Kathy Kennedy at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep Disorders
What is being tested?
Stress Management and Healthy Sleep Practices
How many people
60 participants
Where
1 siteUnited States
Study dates
Feb 2003to Nov 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: AgeWise Project 2: Reducing Stress and Sleep Disturbances in Caregivers of Patients With Progressive Dementia

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.

Read the 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.
Conditions
Sleep Disorders
Being tested
Stress Management and Healthy Sleep Practices
Keywords
Caregiving, Spousal, Sleep disturbances, 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
Medical subject headings
Sleep Wake Disorders, Parasomnias, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stress Management and Healthy Sleep PracticesBehavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Polysomnography pre and post intervention

    collection of physiological \& psychological variables pre and post BBTI sleep disturbances and stress in caregivers

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionNov 2008
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00178568
Sponsor's protocol ID
021117
Other IDs
1P01AG020677-01
Status last verified
May 2015
First submitted
13 Sep 2005
Last updated
28 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Adler NE, Ostrove JM. Socioeconomic status and health: what we know and what we don't. Ann N Y Acad Sci. 1999;896:3-15. doi: 10.1111/j.1749-6632.1999.tb08101.x.

    PubMed 10681884

  • Aspinwall LG, Taylor SE. A stitch in time: self-regulation and proactive coping. Psychol Bull. 1997 May;121(3):417-36. doi: 10.1037/0033-2909.121.3.417.

    PubMed 9136643

  • Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.

    PubMed 3806354

  • Beharka AA, Meydani M, Wu D, Leka LS, Meydani A, Meydani SN. Interleukin-6 production does not increase with age. J Gerontol A Biol Sci Med Sci. 2001 Feb;56(2):B81-8. doi: 10.1093/gerona/56.2.b81.

    PubMed 11213271

  • Beneke M. Methodological investigations of the Hamilton Anxiety Scale. Pharmacopsychiatry. 1987 Nov;20(6):249-55. doi: 10.1055/s-2007-1017116.

    PubMed 3432359

  • Bernstein E, Kaye D, Abrutyn E, Gross P, Dorfman M, Murasko DM. Immune response to influenza vaccination in a large healthy elderly population. Vaccine. 1999 Jan;17(1):82-94. doi: 10.1016/s0264-410x(98)00117-0.

    PubMed 10078611

  • Bixler EO, Vgontzas AN, Lin HM, Ten Have T, Rein J, Vela-Bueno A, Kales A. Prevalence of sleep-disordered breathing in women: effects of gender. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):608-13. doi: 10.1164/ajrccm.163.3.9911064.

    PubMed 11254512

  • Bixler EO, Vgontzas AN, Ten Have T, Tyson K, Kales A. Effects of age on sleep apnea in men: I. Prevalence and severity. Am J Respir Crit Care Med. 1998 Jan;157(1):144-8. doi: 10.1164/ajrccm.157.1.9706079.

    PubMed 9445292

  • Brunner DP, Vasko RC, Detka CS, Monahan JP, Reynolds CF 3rd, Kupfer DJ. Muscle artifacts in the sleep EEG: automated detection and effect on all-night EEG power spectra. J Sleep Res. 1996 Sep;5(3):155-64. doi: 10.1046/j.1365-2869.1996.00009.x.

    PubMed 8956205

  • Burkman RT, Collins JA, Greene RA. Current perspectives on benefits and risks of hormone replacement therapy. Am J Obstet Gynecol. 2001 Aug;185(2 Suppl):S13-23. doi: 10.1067/mob.2001.117414.

    PubMed 11521118

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Carrier J, Monk TH, Buysse DJ, Kupfer DJ; New Collective Author. Sleep and morningness-eveningness in the 'middle' years of life (20-59 y). J Sleep Res. 1997 Dec;6(4):230-7. doi: 10.1111/j.1365-2869.1997.00230.x.

    PubMed 9493522

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PubMed 3558716

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Coleman RM, Roffwarg HP, Kennedy SJ, Guilleminault C, Cinque J, Cohn MA, Karacan I, Kupfer DJ, Lemmi H, Miles LE, Orr WC, Phillips ER, Roth T, Sassin JF, Schmidt HS, Weitzman ED, Dement WC. Sleep-wake disorders based on a polysomnographic diagnosis. A national cooperative study. JAMA. 1982 Feb 19;247(7):997-1003. No abstract available.

    PubMed 7057593

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disorders, run by Kathy Kennedy at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Polysomnography pre and post intervention (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00178568, which also lists 88 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.

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