Sleep and Circadian Rhythm + Memory Support for Sleep Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Berkeley
No Placebo Group
Trial Summary
What is the purpose of this trial?Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.
How is the Memory Support Intervention treatment different from other treatments for sleep disorders?
The Memory Support Intervention is unique because it targets both sleep and circadian rhythm disruptions, which are linked to memory issues, especially in older adults. This approach is novel as it aims to restore regular circadian rhythms, potentially preventing or slowing neurodegenerative diseases and improving cognitive function.
134912Is the Sleep and Circadian Rhythm + Memory Support treatment safe for humans?
The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) has been studied in community settings, but the available research does not provide specific safety data for humans. Further studies are needed to establish its safety profile.
26101112What data supports the effectiveness of the treatment Memory Support Intervention (MSI) for sleep disorders?
Research shows that similar treatments, like the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), have been effective in improving sleep and mental health outcomes. Additionally, interventions targeting sleep in older adults with mild cognitive impairment have shown improvements in sleep quality, which is linked to better cognitive health.
567810Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for individuals aged 50 and older who speak English, have mobility issues, low income, and show no signs of cognitive impairment. They must be experiencing sleep or circadian disturbances but not severe untreated sleep apnea or other conditions that severely affect sleep. Participants need to consent to communication between researchers and their medical providers.Participant Groups
The study tests a new Memory Support Intervention (MSI) designed to improve treatment outcomes by enhancing patient memory. It focuses on people with mental illness suffering from sleep disorders and aims to see if MSI can better their sleep patterns, daily functioning, and memory retention.
2Treatment groups
Experimental Treatment
Active Control
Group I: TranS-C+MSIExperimental Treatment2 Interventions
Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention
Group II: TranS-C aloneActive Control1 Intervention
The Transdiagnostic Sleep and Circadian Intervention will be delivered alone
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of California, BerkeleyBerkeley, CA
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Who is running the clinical trial?
University of California, BerkeleyLead Sponsor
References
Chronobiological rhythm constraints of memory processes. [2008]Memory performances are not constant but undergo fluctuations whose periodicity may be analyzed. Low frequency infradian rhythms (periods longer than 28 hours), circadian rhythms (periods between 20 and 28 hours) and ultradian rhythms (periods less than 20 hours) are involved in memory disorders. Paradoxical sleep represents a preferential period in which certain processes, such as the activation of the central nervous system for example, may facilitate learning process. Relations between sleep and memory lead to the discussion of the incidence of the cyclic nature of sleep (and notably the rhythm of 90 minutes' paradoxical sleep) on the daily course of cerebral activation and its effects on the variable aptitude of our capacity for remembering. The close interrelation between biological rhythms and cognition is demonstrated using two examples of mental disorders in which severe memory deficiencies are observed.
Sleep habits in mild cognitive impairment. [2021]We explored the relationship between sleep disturbances and mild cognitive impairment (MCI) in community-dwelling seniors. Recent evidence suggests that sleep habits are differentially compromised in different subtypes of MCI, but the relationship between sleep disruption and MCI remains poorly understood. We gathered daily objective measures of sleep disturbance from 45 seniors, including 16 with MCI (mean age, 86.9±4.3 y), over a 6-month period. We also collected self-report measures of sleep disturbance. Although there were no differences between groups in any of our self-report measures, we found that amnestic MCI (aMCI) volunteers had less disturbed sleep than both nonamnestic MCI (naMCI) and cognitively intact volunteers, as measured objectively by movement in bed at night (F2,1078=4.30, P=0.05), wake after sleep onset (F2,1078=41.6, P
Hippocampal activity mediates the relationship between circadian activity rhythms and memory in older adults. [2022]Older adults experience parallel changes in sleep, circadian rhythms, and episodic memory. These processes appear to be linked such that disruptions in sleep contribute to deficits in memory. Although more variability in circadian patterns is a common feature of aging and predicts pathology, little is known about how alterations in circadian activity rhythms within older adults influence new episodic learning. Following 10 days of recording sleep-wake patterns using actigraphy, healthy older adults underwent fMRI while performing an associative memory task. The results revealed better associative memory was related to more consistent circadian activity rhythms, independent of total sleep time, sleep efficiency, and level of physical activity. Moreover, hippocampal activity during successful memory retrieval events was positively correlated with associative memory accuracy and circadian activity rhythm (CAR) consistency. We demonstrated that the link between consistent rhythms and associative memory performance was mediated by hippocampal activity. These findings provide novel insight into how the circadian rhythm of sleep-wake cycles are associated with memory in older adults and encourage further examination of circadian activity rhythms as a biomarker of cognitive functioning.
Non-rapid eye movement sleep instability in mild cognitive impairment: a pilot study. [2016]Polysomnographic (PSG) studies in mild cognitive impairment (MCI) are not conclusive and are limited only to conventional sleep parameters. The aim of our study was to evaluate sleep architecture and cyclic alternating pattern (CAP) parameters in subjects with MCI, and to assess their eventual correlation with cognition.
Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. [2022]Improving the sleep of older adults with mild cognitive impairment (MCI) represents a first step in discovering whether interventions directed at modifying this risk factor also have the potential to alter the cognitive decline trajectory.
Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment. [2018]Current evidence suggests that good quality sleep is associated with preserved cognitive function and reduced dementia risk in older adults. Sleep complaints are especially common among older adults with mild cognitive impairment (MCI), and this may contribute to their increased risk for progression to dementia. Thus, improving their sleep may be important for maintaining their cognitive health. Chronotherapy is a set of intervention strategies that can improve sleep quality through strengthening the entrainment of the biological clock to the solar light-dark cycle, and includes strategies such as (1) bright light therapy (BLT); (2) physical activity (PA); and (3) good sleep hygiene. Of these strategies, BLT is the most potent and is based on providing individualized timing to entrain circadian rhythms. Thus, a personalized chronotherapy intervention of individually timed BLT and individually tailored PA promotion, in conjunction with general sleep hygiene education may promote older adult sleep quality. We therefore aim to carry out a proof-of-concept randomized controlled trial (RCT) to examine the efficacy of such a personalized chronotherapy intervention to improve sleep quality among older adults with MCI.
"Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study. [2020]Objective/Background: Sleep-wake disturbance is associated with poor cognitive functioning and several other adverse outcomes that increase dementia risk in older adults. Targeting sleep-wake disturbance in individuals at risk for dementia may be an important treatment. This study evaluated the efficacy of a four-session multicomponent group intervention for participants with mild cognitive impairment (MCI). Participants: Thirty-five older adults with MCI (mean age = 69.7 years, SD = 9.1), were recruited. MCI was determined via consensus from neuropsychological, medical, and neurological review. Methods: Participants were randomized to the "Sleep Well, Think Well" (SWTW) group condition or a passive control group. The SWTW group received four fortnightly face-to-face sessions conducted by an experienced sleep psychologist and neuropsychologist. The control group received written material detailing strategies to improve sleep quality. Both groups received fortnightly coaching phone calls. The primary outcome was subjective sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes included actigraphy sleep measures, daytime sleepiness, cognitive functioning, and depression severity. Results: The SWTW intervention was associated with a large and statistically significant improvement in subjective sleep quality (Cohen's d = 0.83, p < 0.02). A moderate nonsignificant effect was evident in reducing daytime sleepiness (Cohen's d = 0.70, p = .08). No significant effects were found on actigraphy markers, depressive symptoms, or tests of cognitive functioning. Conclusions: The eight-week SWTW group intervention for MCI significantly improved subjective sleep quality when compared with a passive control condition. The program also had a moderate (nonsignificant) effect on reducing daytime sleepiness.
A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. [2021]This study examined the 6-month follow-up outcomes of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), compared to Psychoeducation about sleep and health (PE).
Associations of actigraphic sleep and circadian rest/activity rhythms with cognition in the early phase of Alzheimer's disease. [2023]To compare sleep and circadian rest/activity rhythms (RARs), quantified by standard and novel actigraphic metrics, between controls and participants with mild cognitive impairment (MCI), and to examine the cross-sectional relationships between these measures and cognition.
A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. [2022]To determine if the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) improves functional impairment, psychiatric symptoms, and sleep and circadian functioning.
Outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in a community setting: Unpacking comorbidity. [2021]Comorbidity and subdiagnostic symptoms are understudied for sleep and circadian problems. We evaluated 1) impairment associated with (a) number of sleep and circadian problems and (b) diagnostic threshold (full diagnosis vs. subdiagnostic symptoms), and 2) Transdiagnostic Sleep and Circadian Intervention (TranS-C) outcomes for participants with specific sleep and circadian problems.
Circadian Rhythm Changes in Healthy Aging and Mild Cognitive Impairment. [2023]Disruptions in circadian rhythms can occur in healthy aging; however, these changes are more severe and pervasive in individuals with age-related and neurodegenerative diseases, such as dementia. Circadian rhythm alterations are also present in preclinical stages of dementia, for example, in patients with mild cognitive impairments (MCI); thus, providing a unique window of opportunity for early intervention in neurodegenerative disorders. Nonetheless, there is a lack of studies examining the association between relevant changes in circadian rhythms and their relationship with cognitive dysfunctions in MCI individuals. In this review, circadian system alterations occurring in MCI patients are examined compared to healthy aging individuals while also considering their association with MCI neurocognitive alterations. The main findings are that abnormal circadian changes in rest-activity, core body temperature, melatonin, and cortisol rhythms appear in the MCI stage and that these circadian rhythm disruptions are associated with some of the neurocognitive deficits observed in MCI patients. In addition, preliminary evidence indicates that interventions aimed at restoring regular circadian rhythms may prevent or halt the progress of neurodegenerative diseases and mitigate their related cognitive impairments. Future longitudinal studies with repeated follow-up assessments are needed to establish the translational potential of these findings in clinical practice.