Clinical trial NCT04364191: Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Official title: Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Insomnia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-04-28
Enrollment: 27
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pharmaceutical insomnia treatment. To address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. The findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Sleep Latency
timeFrame: immediately post-intervention (4-5weeks after the start of the intervention)
measure: Sleep Latency
timeFrame: 3 months post intervention
measure: Health Related Quality of Life (HRQOL)
timeFrame: immediately post-intervention (4-5weeks after the start of the intervention)
measure: Health Related Quality of Life (HRQOL)
timeFrame: 3 months post intervention
Secondary outcomes:
measure: Wake After Sleep Onset (WASO)
timeFrame: immediately post intervention (4-5weeks after the start of the intervention)
measure: Wake After Sleep Onset (WASO)
timeFrame: 3 months post intervention
measure: Total Sleep Time (TST)
timeFrame: immediately post intervention
measure: Total Sleep Time (TST)
timeFrame: 3 months post intervention
measure: Sleep Efficiency (SE)
timeFrame: immediately post intervention
measure: Sleep Efficiency (SE)
timeFrame: 3 months post intervention
measure: Self- Reported Insomnia Symptoms
timeFrame: immediately post intervention
measure: Self- Reported Insomnia Symptoms
timeFrame: 3 months post intervention
measure: Self-reported Sleep Quality
timeFrame: immediately post intervention
measure: Self-reported Sleep Quality
timeFrame: 3 months post intervention
Other outcomes:
measure: Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis
timeFrame: Immediately post intervention
measure: Number of Participants Who Completed the Dried Blood Spot Sample for Inflammatory Biomarker Analysis
timeFrame: 3 months post intervention
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: