Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- University of Pennsylvania
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Sleep Latency
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age 55 and older
- •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.
- •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
- •live in the community
- •speak English as primary language
Exclusion Criteria
- •Presence of moderate to severe cognitive impairment defined as TICS score \<28
- •Visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting a number at 24 point font
- •Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
- •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
Outcomes
Primary Outcomes
Sleep Latency
Time Frame: 3 months post intervention
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
Health Related Quality of Life (HRQOL)
Time Frame: 3 months post intervention
RAND Medical Outcomes Study Short Form-36 (SF-36) is a multidomain scale that measures physical and mental components of HRQOL with eight subscales. The 8 subscales include physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue, and general health. All sub scales range from 0 to 100 (lower scores indicate worse HRQOL). For this primary analysis, we are using the general health sub scale, ranging from 0 to 100, where lower scores indicate worse HRQOL.
Secondary Outcomes
- Wake After Sleep Onset (WASO)(3 months post intervention)
- Sleep Efficiency (SE)(3 months post intervention)
- Total Sleep Time (TST)(3 months post intervention)
- Self-reported Sleep Quality(3 months post intervention)
- Self- Reported Insomnia Symptoms(3 months post intervention)