Improving Dementia Caregiver Sleep & the Effect on Heart Disease Biomarkers

Completed · Not applicable

Conditions studied: Caregivers of Persons With Dementia

In brief

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.

Key facts

Study ID

NCT01550172

Run by

University of South Florida

People needed

80

Starts

2012-04-01

Expected to finish

2016-07-01

Last updated by the study team

2016-10-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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