The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Each treatment consists of 600 TMS pulses (\~3 minutes) applied to the L-DLPFC
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGInsomnia Severity Index
The Insomnia Severity Index (ISI) is a brief self-assessment tool used to measure the severity of insomnia. It consists of seven questions that evaluate sleep problems, their impact on daily life, and the individual's level of concern about their sleep issues. The total score helps to categorize the severity of insomnia from mild to severe.
Time frame: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
Paired Associative Learning test (CANTAB)
The Paired Associative Learning (PAL) test is a computer-based cognitive assessment that evaluates memory and learning. In the test, participants are shown patterns and must remember the locations of these patterns on a screen. It is commonly used to assess spatial memory and detect early signs of memory-related conditions like Alzheimer's disease.
Time frame: Baseline, Week 3, Week 12, 6 Months
Spatial Working Memory test (CANTAB)
The Spatial Working Memory (SWM) test is a computer-based task used to assess the ability to retain and manipulate spatial information. Participants must find hidden tokens within a series of boxes while avoiding revisiting previously searched locations. This test measures executive function and memory, and is often used in research on conditions affecting cognitive function.
Time frame: Baseline, Week 3, Week 12, 6 months
Multidimensional Fatigue Symptoms Inventory
The Multidimensional Fatigue Symptom Inventory (MFSI) is a questionnaire designed to assess different aspects of fatigue. It measures five dimensions: general fatigue, emotional fatigue, physical fatigue, mental fatigue, and vigor (energy levels). The tool helps to provide a comprehensive understanding of an individual's fatigue symptoms and their impact on daily functioning.
Time frame: Baseline, Week 3, Week 12, 6 months
Center for Epidemiologic Studies Depression scale
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The Center for Epidemiologic Studies Depression scale (CES-D) is a self-report questionnaire designed to measure symptoms of depression in the general population. It consists of 20 questions that assess mood, behavior, and physical symptoms associated with depression over the past week. The CES-D is commonly used in research and clinical settings to screen for depressive symptoms and monitor changes in mood.
Time frame: Baseline, Week 3, Week 12, 6 months
Match to Sample Visual Search test (CANTAB)
The Match to Sample Visual Search (MTS) test is a computerized assessment that measures visual recognition and attention. In the test, participants are shown a sample pattern and must quickly identify the matching pattern from a selection of similar images. It evaluates processing speed, visual memory, and attention to detail, and is often used to study cognitive functions in various neurological and psychiatric conditions.
Time frame: Baseline, Week 3, Week 12, 6 months
Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a quick test used by doctors and other healthcare professionals to check a person's thinking and memory skills. It takes about 10-15 minutes and looks at things like attention, memory, language, and problem-solving. It's often used to help spot early signs of conditions like dementia or mild cognitive impairment.
Time frame: Baseline, Week 3, Week 12, 6 months
Sleep efficiency (sleep diaries)
Sleep Efficiency is a measure derived from sleep diaries that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.
Time frame: Week 3, Week 13, 6 months
Sleep After Wake Onset (sleep diaries)
Sleep After Wake Onset (SAWO) is a measure derived from sleep diaries that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.
Time frame: Week 3, Week 13, Week 40
Sleep Onset Latency (sleep diaries)
Sleep Onset Latency (SOL) is a measure derived from sleep diaries that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.
Time frame: Week 3, Week 13, Week 40
Sleep efficiency (actigraphy)
Sleep Efficiency is a measure derived from actigraphy that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings.
Time frame: Week 3, Week 13, 6 months
Sleep After Wake Onset (actigraphy)
Sleep After Wake Onset (SAWO) is a measure derived from actigraphy that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions.
Time frame: Week 3, Week 13, Week 40
Sleep Onset Latency (actigraphy)
Sleep Onset Latency (SOL) is a measure derived from actigraphy that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation.
Time frame: Week 3, Week 13, Week 40