Clinical Trials Logo

Clinical Trial Summary

Poor sleep quality is a known risk factor for cognitive decline in the elderly. Hearteningly, sleep is also a prime target for behavioral modification. In this study, the investigators propose to test mindfulness-based training (MBT) as an intervention to improve sleep quality by reducing sleep fragmentation, and hypothesize that these improvements will mediate the beneficial effects of MBT on sustained and executive attention. MBT consists of a suite of techniques aimed at enhancing awareness and acceptance of one's internal (e.g., thoughts and feelings) and external experiences in the present moment. Learning these techniques has been shown to improve sleep quality in patients with primary insomnia, and in other conditions associated with sleep disturbance. There is also increasing evidence that mindfulness training enhances multiple facets of cognition, including components of attention. In this study, the investigators will recruit 120 participants in a randomized controlled design, with 60 participants receiving MBT, and 60 receiving a sleep hygiene education and exercise program (SHEEP). Each intervention will last 8 weeks. Before and after the intervention, the investigators will collect objective and subjective measures of sleep quality, resting-state and task-related functional magnetic resonance imaging scans, and performance on standard laboratory tests of attention. The investigators hypothesize that, relative to SHE, MBT will result in significantly greater improvements in sleep quality and attentional metrics. They also predict that the cognitive changes will be mediated by the changes in sleep quality. If a positive result is found, this would indicate the use of MBT as a cost-effective behavioral intervention to stabilize or even improve cognition in the elderly, thus reducing the risk of dementia in this vulnerable population.


Clinical Trial Description

Cognitive decline in the elderly is a rapidly growing concern in Singapore and other developed Asian nations. Among the major but understudied factors that may exacerbate this decline is poor sleep quality. Targeting sleep to decelerate or even reverse age-related cognitive decline may represent a low-cost, high-return solution to a widespread societal problem. To accomplish this goal, the investigators propose to test mindfulness-based training (MBT) as an intervention to improve sleep quality and cognition. In this pilot grant, the investigators will study a group of participants (N = 120) in a randomized controlled design pitting MBT (N =60) against sleep hygiene education (SHEEP, N = 60). Hypothesis 1: MBT will lead to significantly greater improvements in sustained and executive attention relative to SHEEP (measured both behaviorally and using functional magnetic resonance imaging). Hypothesis 2: Cognitive outcomes will be mediated by improvements in subjective and objective sleep quality. Good sleep is critical for cognition at all ages, and especially in the elderly Adequate sleep is important for optimal cognitive function across the lifespan. Although the association between sleep and cognitive function is bi-directional, alterations in sleep frequently occur prior to the appearance of cognitive symptoms in Alzheimer's Disease (AD). Almost 50% of older adults report at least one sleep problem, and there is growing evidence that sleep complaints and disturbances might have negative effects on cognition. Retired older adults have the freedom to sleep ad libitum but this benefit is offset by age-associated changes in sleep such as poorer subjective quality, increased fragmentation and/or altered macrostructure. Although sleep duration is the measure that has received the most attention, there is accumulating evidence that sleep quality (Blackwell et al., 2014) and sleep fragmentation in particular, can have deleterious effects on brain structure and cognition. A change in sleep pattern in late adulthood can foreshadow cognitive decline, perhaps as a result of accumulation of neurotoxic substances that are normally cleared during sleep. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03677726
Study type Interventional
Source Singapore General Hospital
Contact
Status Completed
Phase N/A
Start date August 1, 2018
Completion date June 10, 2021

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Recruiting NCT05000528 - Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia N/A
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT01784614 - A Study of LY2624803 in Japanese Participants With Transient Insomnia Phase 1
Completed NCT00380003 - Efficacy Study of EVT 201 to Treat Insomnia Phase 2
Completed NCT00365261 - Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer Phase 4
Completed NCT00183378 - Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease N/A
Completed NCT00097604 - Effects of Valerian on Sleep in Healthy Older Adults Phase 2
Completed NCT00946530 - Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease N/A
Completed NCT00630175 - Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia Phase 3
Completed NCT00079664 - Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults Phase 1
Completed NCT00044629 - Combined Behavioral/Pharmacological Therapy for Insomnia Phase 2
Completed NCT01154023 - Behavioral Intervention for Insomnia in Older Adults N/A
Recruiting NCT04417153 - Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Recruiting NCT04986007 - Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults N/A
Completed NCT03852966 - Better Sleep in Psychiatric Care - ADHD Pilot Study N/A
Terminated NCT00750919 - Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007) Phase 3
Recruiting NCT04550507 - Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents N/A