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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sleep Latency
time it takes a person to fall asleep, starting from first intention to sleep, measured by sleep diary
Time frame: immediately post-intervention (4-5weeks after the start of the intervention)
Sleep Latency
time it takes a person to fall asleep, starting from first intention to sleep; measured by sleep diary
Time frame: 3 months post intervention
Health Related Quality of Life (HRQOL)
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.
Time frame: immediately post-intervention (4-5weeks after the start of the intervention)
Health Related Quality of Life (HRQOL)
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.
Time frame: 3 months post intervention
Wake After Sleep Onset (WASO)
time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep
Time frame: immediately post intervention (4-5weeks after the start of the intervention)
Wake After Sleep Onset (WASO)
time (in minutes) a person spends awake during the night, starting from the time the person falls asleep; derived from actigraphy monitoring; more WASO indicates worse sleep
Time frame: 3 months post intervention
Total Sleep Time (TST)
Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes
Time frame: immediately post intervention
Total Sleep Time (TST)
Actual time (in minutes) a person is asleep during the nighttime sleep period; derived from actigraphy monitoring; normal sleep ranges from 420-480 minutes
Time frame: 3 months post intervention
Sleep Efficiency (SE)
Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep
Time frame: immediately post intervention
Sleep Efficiency (SE)
Percent of time spent in bed that a person is asleep; calculated from actigraphy (time asleep/ time in bed)x 100%; lower SE indicates worse sleep
Time frame: 3 months post intervention
Self- Reported Insomnia Symptoms
measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)
Time frame: immediately post intervention
Self- Reported Insomnia Symptoms
measured with the Insomnia Severity Index; score ranges from 0-28, with higher scores indicating more insomnia symptoms (thus worse outcomes)
Time frame: 3 months post intervention
Self-reported Sleep Quality
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Time frame: immediately post intervention
Self-reported Sleep Quality
measured with Pittsburgh Sleep Quality Index; score ranges from 0-21 with higher scores indicating poor sleep quality (worse outcomes)
Time frame: 3 months post intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.