Status:
COMPLETED
Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Mild Cognitive Impairment
Insomnia
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
Insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharma...
Eligibility Criteria
Inclusion
- 1\) age 55 and older
- 2\) mild cognitive impairment (MCI) The Telephone Interview for Cognitive Status 13-item modified (TICS-M) version will be used to screen participants for eligibility in the study. We will include participants with TICS-M scores of 28-36, based off ranges and optimal cutpoints determined in various studies.
- 3\) have insomnia symptoms a)answer yes to "Do you have trouble falling asleep, staying asleep, awakening too early, or have unrefreshing sleep" and b) have subjective sleep diary evidence of insomnia, with an average sleep onset latency \>30 min or wakefulness after sleep onset of \>60 min during the one week pre-treatment assessment
- 4\) live in the community
- 5\) speak English as primary language
Exclusion
- 1\) Presence of moderate to severe cognitive impairment defined as TICS score \<28
- 2\) Visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting a number at 24 point font
- 3\) Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
- 4\) Presence of an acute medical or psychiatric condition which, in the judgement of the research team, would interfere with the subject's ability to realistically follow the study protocol
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04364191
Start Date
May 13 2021
End Date
August 30 2022
Last Update
May 29 2024
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104