Clinical trial NCT03677726: Improving Sleep Continuity Through Mindfulness Training for Better Cognitive Ageing.
Official title: Improving Sleep Continuity Through Mindfulness Training for Better Cognitive Ageing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Cognitive Aging
Keywords: Insomnia
Cognitive aging
Mindfulness
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
First posted: 2018-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either a Mindfulness-based Therapy for Insomnia (MBTI) or a Sleep Hygiene Education Program (SHEP). The intervention is for 8 weeks. Measures will be administered prior to and on completion of the intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 50 to 80
2. English-speaking
3. Mini-Mental State Examination Score ≥ 26
4. Montreal Cognitive Assessment Score ≥ 23

At least one of the following sleep difficulties are expressed:

(i) average reported sleep latency of more than 30 minutes

(ii) average wakefulness after sleep onset of more than 30 minutes

(iii) sleep efficiency or total sleep time of less than 6.5 hours

and/or

(iv) also a cut off in the PSQI\>/=5

Exclusion Criteria:

1. Presence of major neurological conditions such as epilepsy, stroke, Parkinson's Disease and/or brain injury
2. Presence of major psychiatric conditions such as major depression or schizophrenia
3. Unsuitability for fMRI scanning (e.g. pacemakers, metallic implants, claustrophobia)
4. Unable to give independent consent or no consent available

Primary outcomes:
measure: Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index Score
timeFrame: Up to one month
measure: Polysomnography: objective changes in sleep onset latency (SOL)
timeFrame: One night
measure: Actiwatch: objective changes in sleep onset latency (SOL)
timeFrame: One week
measure: Polysomnography: objective changes in wake after sleep onset (WASO)
timeFrame: One night
measure: Actiwatch: objective changes in wake after sleep onset (WASO)
timeFrame: One week
measure: Change in Subjective measures of Sleep quality: Insomnia Severity Index
timeFrame: Past two weeks
measure: Change in Cognitive and Attention tasks performance (CANTAB: Reaction time task)
timeFrame: Up to 10 minutes
measure: Change in Cognitive and Attention tasks performance (CANTAB: Rapid Visual Information Processing primary outcome)
timeFrame: Up to 10 minutes
measure: Change in Cognitive and Attention tasks performance (CANTAB: Paired Associate Learning)
timeFrame: Up to 10 minutes
measure: Change in Cognitive and Attention tasks performance (CANTAB: Spatial Working Memory)
timeFrame: Up to 10 minutes
measure: Change in Cognitive and Attention tasks performance (CANTAB: Stocking of Cambridge)
timeFrame: Up to 10 minutes
Secondary outcomes:
measure: Imaging measures (structural): change in orbitofrontal cortex volume
timeFrame: 6 minutes
measure: Change in functional imaging measures: Resting state and Inscape
timeFrame: 10 minutes
measure: Change in functional imaging measures: Breath counting task
timeFrame: 10 minutes
measure: Change in functional imaging measures: Letting go practice
timeFrame: 10 minutes
measure: Change in Cognitive and Attention tasks performance (CANTAB: Emotion Recognition Task)
timeFrame: Up to 10 minutes
measure: Change in Cognitive and Attention tasks performance (CANTAB: Verbal Recognition Memory)
timeFrame: Up to 10 minutes
measure: Change in Cognitive and Attention tasks performance (CANTAB: Rapid Visual Information Processing)
timeFrame: Up to 10 minutes
measure: Behavioral Breath counting task: Errors
timeFrame: 20 minutes
measure: Behavioral Breath counting task: Accuracy
timeFrame: 20 minutes
measure: Pen and Pencil cognitive test: Colour Trails A and B
timeFrame: Up to 30 minutes
measure: Pen and Pencil cognitive test: IQ Advances Progressive Matrices I and II
timeFrame: Up to 30 minutes
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Past one month
measure: Change in Subjective measures of Sleep quality: Dysfunctional Beliefs and Attitudes about Sleep
timeFrame: Past one month
measure: Change in Subjective measures of Sleep quality: Pre-Sleep Arousal,
timeFrame: Past one month
measure: Change in Subjective measures about mood, anxiety and quality of life: State Trait Anxiety Inventory
timeFrame: Past year
measure: Change in Subjective measures about mood, anxiety and quality of life: Beck's Depression Inventory,
timeFrame: Up to last year
measure: Change in Subjective measures about mood, anxiety and quality of life: Short-Form 36
timeFrame: Up to last year
measure: Polysomnography: objective changes in total sleep time (TST)
timeFrame: One night
measure: Actiwatch: objective changes in total sleep time (TST)
timeFrame: One week
measure: Change in oxygen levels during sleep
timeFrame: One night
measure: Heart rate during sleep
timeFrame: One night
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Kinjal Doshi
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke-NUS Graduate Medical School
name: Julian Lim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim J, Teng J, Patanaik A, Tandi J, Massar SAA. Dynamic functional connectivity markers of objective trait mindfulness. Neuroimage. 2018 Aug 1;176:193-202. doi: 10.1016/j.neuroimage.2018.04.056. Epub 2018 Apr 27.
citation: F Wong K, A A Massar S, Chee MWL, Lim J. Towards an Objective Measure of Mindfulness: Replicating and Extending the Features of the Breath-Counting Task. Mindfulness (N Y). 2018;9(5):1402-1410. doi: 10.1007/s12671-017-0880-1. Epub 2018 Jan 22.
citation: Blackwell T, Yaffe K, Laffan A, Ancoli-Israel S, Redline S, Ensrud KE, Song Y, Stone KL; Osteoporotic Fractures in Men (MrOS) Study Group. Associations of objectively and subjectively measured sleep quality with subsequent cognitive decline in older community-dwelling men: the MrOS sleep study. Sleep. 2014 Apr 1;37(4):655-63. doi: 10.5665/sleep.3562.
citation: Lim J, Dinges DF. A meta-analysis of the impact of short-term sleep deprivation on cognitive variables. Psychol Bull. 2010 May;136(3):375-89. doi: 10.1037/a0018883.
citation: Ju YE, Lucey BP, Holtzman DM. Sleep and Alzheimer disease pathology--a bidirectional relationship. Nat Rev Neurol. 2014 Feb;10(2):115-9. doi: 10.1038/nrneurol.2013.269. Epub 2013 Dec 24.
citation: Lim AS, Kowgier M, Yu L, Buchman AS, Bennett DA. Sleep Fragmentation and the Risk of Incident Alzheimer's Disease and Cognitive Decline in Older Persons. Sleep. 2013 Jul 1;36(7):1027-1032. doi: 10.5665/sleep.2802.