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Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers

NCT ID: NCT01550172

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-07-31

Brief Summary

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The purpose of the study is to determine whether a combined intervention of a night home monitoring system and cognitive-behavioral therapy for insomnia (CBTi) is effective in improving sleep in dementia caregivers who arise at night.

Detailed Description

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Informal caregivers provide the majority of care for chronically ill adults, including persons with dementia. While these individuals provide a great benefit to the chronically ill relative, being a caregiver is associated with deleterious health consequences, including premature mortality and higher rates of coronary heart disease (CHD). Another common complaint among dementia caregivers is poor sleep, which has been connected to premature mortality and higher rates of CHD in noncaregiving adults. Currently no sleep therapies are empirically validated as effective for caregivers of persons with dementia (PWD), and since PWD often arise at night, improving caregiver sleep could be potentially hazardous as a sleeping caregiver cannot provide supervision during night awakenings. Our primary purpose is thus to determine whether a combined intervention is effective in improving sleep in caregivers of PWD who arise at night. The intervention consists of a night home monitoring system that provides reliable alerts to caregivers when PWD leave the bed and move through the house. While this system improved home safety for PWD, it did not affect caregiver sleep, so a more traditional sleep therapy will be added-cognitive-behavioral therapy for insomnia. In the proposed study, experimental participants will receive the night home monitoring system + CBTi; active comparator participants will receive the night home monitoring system and sleep behavioral therapy. Participants will remain in the study for 29 weeks, with 4 data collection points. We hypothesize experimental participants will have less time awake after going to bed, and improved sleep efficiency (percent time asleep while in bed). Sleep data will be collected for multiple nights using actigraphy and sleep diary. Our secondary research questions focus on the relationship between poor sleep and CHD. Both in adults and in dementia caregivers, there appears to be a link between poor sleep and abnormal levels on coronary heart disease biomarkers, and likely an increase in CHD with poor sleep. We aim to further explore this relationship as well as determine whether levels of biomarkers improve with improved sleep from the intervention. We propose to draw blood samples at 4 data collection points and measure a set of biomarkers indicative of CHD.

Conditions

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Caregivers of Persons With Dementia

Keywords

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dementia caregivers caregivers Alzheimer's caregivers caregiver sleep heart disease risk dementia Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sleep Behavioral Therapy A and NHMS

Participants in this arm receive behavioral therapy A for insomnia and the night home monitoring system.

Group Type EXPERIMENTAL

Sleep Behavioral Therapy A and NHMS

Intervention Type BEHAVIORAL

The night home monitoring system provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.

Sleep behavioral therapy A uses a combination of cognitive exercises and behavior adjustments.

Sleep Behavioral Therapy B and NHMS

Participants in this arm receive sleep behavioral therapy B and the night home monitoring system.

Group Type ACTIVE_COMPARATOR

Sleep Behavioral Therapy B and NHMS

Intervention Type BEHAVIORAL

The night home monitoring system (NHMS) provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.

Sleep behavioral therapy B uses primarily behavioral adjustments.

Interventions

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Sleep Behavioral Therapy A and NHMS

The night home monitoring system provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.

Sleep behavioral therapy A uses a combination of cognitive exercises and behavior adjustments.

Intervention Type BEHAVIORAL

Sleep Behavioral Therapy B and NHMS

The night home monitoring system (NHMS) provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.

Sleep behavioral therapy B uses primarily behavioral adjustments.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary caregiver for a relative who has been diagnosed by a physician with dementia or Alzheimer's disease.
* Persons with dementia sleep in the same location each night.
* Caregiver provides care for persons with dementia with nighttime activity that occurs at least one night/week.
* Caregiver meets the standard criteria for Insomnia.
* Caregiver sleep problems affect daytime functioning.
* If caregiver uses sleep medication, dose stable for 6 months.
* Caregiver Telephone Interview for Cognitive Status Score \> 25.
* Caregiver does not require assistive devices to walk in the home at night.

Exclusion Criteria

* Caregiver receives respite care at night the majority of the time.
* Caregiver has diagnosed sleep disorder.
* Caregiver uses CPAP at night
* Caregiver has chronic illness that requires frequent, weekly treatment/assessment by a healthcare provider.
* Current use of anticoagulant medication by the caregiver.
* Caregiver Sleep Apnea-Hypopnea Index (AHI) score \> 10 or \> 15 if pulse oximetry ≥ 88%.
* Caregiver shows evidence of Restless Leg Syndrome per the Cambridge-Hopkins Restless Leg Syndrome Questionnaire.
* Montreal Cognitive Assessment (MOCA) score \< 26.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Meredith Rowe

Meredeth A. Rowe, RN, PhD Professor and Lewis & Leona Hughes Endowed Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meredeth Rowe, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

References

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Roth AJ, Curtis AF, Rowe MA, McCrae CS. Using Telehealth to Deliver Cognitive Behavioral Treatment of Insomnia to a Caregiver of a Person With Alzheimer's Disease. J Cogn Psychother. 2022 Feb 1;36(1):3-23. doi: 10.1891/JCPSY-D-20-00055.

Reference Type DERIVED
PMID: 35121676 (View on PubMed)

Other Identifiers

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1R01AG039495-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6201111800

Identifier Type: -

Identifier Source: org_study_id