Alzheimer Disease Clinical Trial
Official title:
The Feasibility of a Tailored Music Intervention to Reduce Symptoms of Sleep Disruption in Older Adults With Dementia
NCT number | NCT04157244 |
Other study ID # | 829256 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 12, 2019 |
Est. completion date | January 12, 2021 |
Verified date | January 2021 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The specific aims of this studyare to examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of a tailored music intervention in home-dwelling older adults with dementia suffering from sleep disruption. Sixty dyads (older adults with dementia and their caregivers) will be randomized to receive the tailored music intervention immediately or following a four week delay.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 12, 2021 |
Est. primary completion date | January 12, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | Inclusion Criteria: - Age 60 and older - Physician diagnosis of probable ADRD using standard assessments and diagnostic criteria - Presence of sleep problems determined first during phone screening using NPI sleep disorders item, then using proxy-rated Sleep Disorders Inventory (SDI) (presence of at least one sleep disturbance symptom of moderate severity) - Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia or opioids in the past 90 days (typical time frame in clinical trials) prior to enrollment to minimize confounding effects of medications - Tolerates and agrees to wear wrist actigraph - Responsive to their environment (e.g., able to understand short commands) - Sufficient English to complete questionnaires Exclusion Criteria: - Planned transition to another residential or institutional care setting in less than 3 months - Hearing impairment (defined as inability to hear a normal speaking voice at a distance of 1-1/2 feet) - Presence of extrapyramidal symptoms affecting non-dominant hand which may include persons with the following diagnoses: schizophrenia, bipolar disorder, Huntington's disease, Parkinson's disease, Lewy Body dementia due to REM sleep disorders - Currently enrolled in an interventional clinical trial for ADRD aimed to improve sleep - Acute sleep disruption within 2 weeks of screening as it may indicate sleep disorders not related to ADRD or delirium - End stage disease (i.e. cancer, bed bound) |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial. JAMA. 2010 Sep 1;304(9):983-91. doi: 10.1001/jama.2010.1253. — View Citation
Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. Targeting and managing behavioral symptoms in individuals with dementia: a randomized trial of a nonpharmacological intervention. J Am Geriatr Soc. 2010 Aug;58(8):1465-74. doi: 10.1111/j.1532-5415.2010.02971.x. Epub 2010 Jul 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study Measures Completion | Number of participants who complete study measures in accordance with protocol schedule of events | Baseline | |
Primary | Study Measures Completion | Number of participants who complete study measures in accordance with protocol schedule of events | 4 weeks | |
Primary | Acceptability of the study components | Two questions from a survey developed by Gitlin and colleagues (2010) which examines satisfaction with participation and perceived benefits.
The survey uses a scale of 1-3 (1- Not at all to 3-A great deal) to rate caregiver perceived 1) overall benefit from participating in the study and 2) improvement in life of person's with dementia. Min score 2, maximum score 6 (with higher scores indicating greater satisfaction and perceived benefits) |
4 weeks | |
Secondary | Objective sleep measures | Measured using an actigraphy bracelet worn by person with dementia for consecutive 24-hour periods for 4 weeks. The actigraph will measure: 1) Sleep latency (Time it takes a person to fall asleep starting from first intention to sleep); 2) Wake after sleep onset (Time awake during the night, beginning from the time person falls asleep); 3) Total sleep duration (Actual time person is asleep) | 4 weeks | |
Secondary | The Quality of Life in Alzheimer's Disease Scale (QOL-AD) | Person with dementia quality of life. The QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks. | Baseline and 4 weeks |
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