Improving Sleep Continuity Through Mindfulness Training for Better Cognitive Ageing.

NCT03677726 | Completed

• 1 other identifier: 2017/2830
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders; Cognitive Aging

Keywords

Insomnia; Cognitive aging; Mindfulness

Outcome Measures

Primary Outcomes (11)

• Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index Score

  Pittsburgh Sleep Quality Index Score (PSQI) is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep disorder, using a cut-off score of 5. The first 4 items are open questions, whereas items 5 to 19 are rated on a 4-point Likert scale. Individual items scores yield 7 components. A total score, ranging from 0 to 21, is obtained by adding the 7 component scores. A score of 5 and above suggests poor sleep quality. A decrease in PSQI score following intervention would reflect and improvement of sleep quality.

  Up to one month

• Polysomnography: objective changes in sleep onset latency (SOL)

  Polysomnography is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. PSG is a comprehensive recording of bio-physiological changes that occur during sleep. It will be performed at night, at the convenience of the participants' home. PSG monitors many body functions including brain, eye movements, muscle activity or skeletal muscle activation and heart rhythm during sleep. The investigators will use a Somnimedics PSG kit. Sleep onset latency reflects the amount of time it takes to participants to fall asleep from the moment they go to bed in the evening, so higher SOL are indicative of poor sleep quality. This objective measure of participants sleep onset latency will judge sleep quality against the subjective measures obtained through the sleep questionnaires.

  One night

• Actiwatch: objective changes in sleep onset latency (SOL)

  Wrist-worn actigraphy is a convenient and reliable way to monitor sleep. It will be performed using research-grade, wrist-worn accelerometers that are calibrated to detect sleep by inferring from movement patterns. The systems used in this proposal (Philips Respironics AW-2 or Spectrum) has been calibrated against PSG. Sleep onset latency reflects the amount of time it takes to participants to fall asleep from the moment they go to bed in the evening, on average over seven nights of recording. This objective measure of participants sleep onset latency will judge sleep quality against the subjective measures obtained through the sleep questionnaires.

  One week

• Polysomnography: objective changes in wake after sleep onset (WASO)

  In addition to Sleep Onset Latency (Primary outcome 2), a second objective measure of sleep quality is extracted from the polysomnography recording: periods of wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed, minus sleep latency and minus total sleep time. High WASO scores reflect low sleep continuity and poor sleep quality. This second measure of participants sleep will judge sleep quality against the subjective measures obtained through the sleep questionnaires.

  One night

• Actiwatch: objective changes in wake after sleep onset (WASO)

  As with measures from PSG, in addition to Sleep Onset Latency (Primary outcome 3), a second objective measure of sleep quality is extracted from the Actiwatch recording: periods of wakefulness occurring after defined sleep onset. WASO is calculated by taking into account the total time spent in bed, minus sleep latency and minus total sleep time, averaged over seven consecutive nights. This second measure of participants sleep will judge sleep quality against the subjective measures obtained through the sleep questionnaires.

  One week

• Change in Subjective measures of Sleep quality: Insomnia Severity Index

  Insomnia Severity Index (ISI) evaluates an individual's level of tendency for insomnia on a 7-item questionnaire, scoring in total from 0 to 28. Scores above 15 indicates moderate severity of clinical insomnia while scores above 22 are indicative of severe clinical insomnia. ISI internal consistency was excellent for population samples both in the community and clinical samples as well, (Cronbach α of 0.90 and 0.91 respectively).

  Past two weeks

• Change in Cognitive and Attention tasks performance (CANTAB: Reaction time task)

  Reaction time task (RTI) provides assays of motor and mental response speeds, as well as measures of movement time, reaction time and response accuracy. Primary outcome: reaction times. Lower reaction times are indicative of better performance.

  Up to 10 minutes

• Change in Cognitive and Attention tasks performance (CANTAB: Rapid Visual Information Processing primary outcome)

  Rapid Visual Information Processing (RVP) is a sensitive tool for assessment of sustained attention. Primary outcomes: median response latency. Lower scores in this measure reflect better sustained attention.

  Up to 10 minutes

• Change in Cognitive and Attention tasks performance (CANTAB: Paired Associate Learning)

  Paired Associate Learning (PAL) assesses visual memory and new learning, and is a sensitive tool for accurate assessment of episodic memory. Primary outcome: accuracy on first trials memory score

  Up to 10 minutes

• Change in Cognitive and Attention tasks performance (CANTAB: Spatial Working Memory)

  Spatial Working Memory (SWM) requires retention and manipulation of visuospatial information. This test has notable executive function demands, and measures strategy use as well as errors. Primary outcome: number of errors.

  Up to 10 minutes

• Change in Cognitive and Attention tasks performance (CANTAB: Stocking of Cambridge)

  Stocking of Cambridge (SOC) assesses spatial planning and requires individuals to use problem-solving strategies to match two sets of stimuli. Primary outcome: number of problems solved on first choice.

  Up to 10 minutes

Secondary Outcomes (21)

• Imaging measures (structural): change in orbitofrontal cortex volume

  6 minutes

• Change in functional imaging measures: Resting state and Inscape

  10 minutes

• Change in functional imaging measures: Breath counting task

  10 minutes

• Change in functional imaging measures: Letting go practice

  10 minutes

• Change in Cognitive and Attention tasks performance (CANTAB: Emotion Recognition Task)

  Up to 10 minutes

Study Arms (2)

Mindfulness Based Therapy for Insomnia

EXPERIMENTAL

The mindfulness-based intervention consists of eight 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion) that pertain to people with sleep problems and insomnia. Participants will be provided handouts for the information covered during these talks and discussions.

Behavioral: Mindfulness Based Therapy for Insomnia

Sleep Hygiene Education Exercise Program

ACTIVE COMPARATOR

The Sleep Hygiene Education and Exercise Program has known relationships with good sleep quality. It will comprise of eight weekly 2-hour sessions. Each session will introduce a concept related to sleep and sleep hygiene. The facilitator will provide the theory and rationale behind the concept, and encourage participants to share and discuss their experiences related to the concept. The session will end with the participants evaluating how to implement the specific concept in their daily lives, and its potential implications for their sleep. Participants will be provided with a manual that outlines the concept and how they intend to apply it to their daily lives.

Other: Sleep Hygiene Education Exercise Program

Interventions

Mindfulness Based Therapy for Insomnia BEHAVIORAL

The mindfulness-based intervention consists of eight 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion) that pertain to people with sleep problems and insomnia. Participants will be provided handouts for the information covered during these talks and discussions.

Also known as: MBTI

Mindfulness Based Therapy for Insomnia

Sleep Hygiene Education Exercise Program OTHER

The Sleep Hygiene Education and Exercise Program has known relationships with good sleep quality. It will comprise 8 weekly 2-hour sessions. Each session will introduce a concept related to sleep and sleep hygiene. The facilitator will provide the theory and rationale behind the concept, and encourage participants to share and discuss their experiences related to the concept. The session will end with the participants evaluating how to implement the specific concept in their daily lives, and its potential implications for their sleep. Participants will be provided with a manual that outlines the concept and how they intend to apply it to their daily lives.

Also known as: SHEEP

Sleep Hygiene Education Exercise Program

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 50 to 80
• English-speaking
• Mini-Mental State Examination Score ≥ 26
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (8)

• 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.

  PMID: 29709625 BACKGROUND

• 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.

  PMID: 30294387 BACKGROUND

• 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.

  PMID: 24899757 BACKGROUND

• 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.

  PMID: 20438143 BACKGROUND

• 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.

  PMID: 24366271 BACKGROUND

• 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.

  PMID: 23814339 BACKGROUND

• Shaif NAS, Doshi K, Lim J. Effects of mindfulness-based therapy for insomnia and a sleep hygiene/exercise programme on subjective-objective sleep discrepancy in older adults with sleep disturbances: Exploratory secondary analysis of a randomised clinical trial. J Sleep Res. 2022 Dec;31(6):e13700. doi: 10.1111/jsr.13700. Epub 2022 Jul 27.

  PMID: 35896519 DERIVED

• Perini F, Wong KF, Lin J, Hassirim Z, Ong JL, Lo J, Ong JC, Doshi K, Lim J. Mindfulness-based therapy for insomnia for older adults with sleep difficulties: a randomized clinical trial. Psychol Med. 2023 Feb;53(3):1038-1048. doi: 10.1017/S0033291721002476. Epub 2021 Jul 1.

  PMID: 34193328 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kinjal Doshi

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

• Julian Lim

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: September 19, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: June 10, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

SG (1)