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Sleep Initiation and Maintenance DisordersMISTNCT03677726

Improving Sleep Continuity Through Mindfulness Training for Better Cognitive Ageing.

A study testing Mindfulness Based Therapy for Insomnia and Sleep Hygiene Education Exercise Program in people with Sleep Initiation and Maintenance Disorders and Cognitive Aging, run by Singapore General Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
What is being tested?
Mindfulness Based Therapy for Insomnia and Sleep Hygiene Education Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSingapore
Study dates
1 Aug 2018to 10 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
  • average reported sleep latency of more than 30 minutes
Show all 10Show fewer
  • average wakefulness after sleep onset of more than 30 minutes
  • sleep efficiency or total sleep time of less than 6.5 hours
  • and/or
  • also a cut off in the PSQI>/=5

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

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.

Read the 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.

Being tested
Mindfulness Based Therapy for Insomnia, Sleep Hygiene Education Exercise Program
Keywords
Insomnia, Cognitive aging, Mindfulness
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Therapy for InsomniaBehavioural

    Also called MBTI

    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.

  • Sleep Hygiene Education Exercise ProgramOther

    Also called SHEEP

    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.

Study groups in NCT03677726
Study groupRoleWhat they receive
Mindfulness Based Therapy for InsomniaExperimentalThe 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.
Receives: Behavioral: Mindfulness Based Therapy for Insomnia
Sleep Hygiene Education Exercise ProgramActive comparatorThe 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.
Receives: Other: Sleep Hygiene Education Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to one month

  2. 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.

    Measured: One night

  3. 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.

    Measured: One week

  4. 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.

    Measured: One night

  5. 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.

    Measured: One week

  6. 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).

    Measured: Past two weeks

  7. 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.

    Measured: Up to 10 minutes

  8. 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.

    Measured: Up to 10 minutes

  9. 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

    Measured: Up to 10 minutes

  10. 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.

    Measured: Up to 10 minutes

  11. 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.

    Measured: Up to 10 minutes

Secondary outcomes (21)

  1. Imaging measures (structural): change in orbitofrontal cortex volume

    Structural and MRI brain scans will be used to assess the change in the volume of orbitofrontal cortex (OFC) - the key region that is both consistently altered by mindfulness meditation, leading to an increase in volume, and implicated in sleep pathology. Participants will have their baseline fMRI scan at least 1-week before the start of their participation in the intervention and after the end of the intervention.

    Measured: 6 minutes

  2. Change in functional imaging measures: Resting state and Inscape

    During two rsfMRI scans, subjects are imaged over several minutes while their eyes are open, but without performing any explicit task. It has been recognized that a person's brain activity at rest contains a rich source of information about their brain function. One of the resting state scan will show only a fixation cross on the screen (resting state), and the second one (Inscape) will show a short video developed in order to minimize the cognitive processing involved while decreasing head movement and sleepiness in the scanner.

    These data are typically extracted by decomposing the time-varying signal during resting periods into independent, intrinsically connected networks. The investigators propose to use traditional connectivity analysis as well as a newer method: graph theory analysis Measure will be increase of task ready state in Dynamic Functional Connectivity, as previous literature suggested that this is positively linked with mindfulness predisposition.

    Measured: 10 minutes

  3. Change in functional imaging measures: Breath counting task

    Main measure is change in cortical activity during sustained attention task, before and after intervention.

    Similar analysis to the resting-state fMRI scans will be conducted to determine the change in Default Mode Network (DMN) and Executive Control Network (ECN) connectivity and anti-correlation between DMN and task-positive networks.

    Measured: 10 minutes

  4. Change in functional imaging measures: Letting go practice

    Change in cortical connectivity while performing a Letting go practice in the scanner. Analysis are similar to the resting state and breath counting task (outcomes 13 and 14).

    Measured: 10 minutes

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

    Emotion Recognition Task: ERT assesses social cognition and measures the ability of the subject to identify emotions in facial expressions. Secondary outcomes: Accuracy and Reaction times.

    Measured: Up to 10 minutes

  6. Change in Cognitive and Attention tasks performance (CANTAB: Verbal Recognition Memory)

    Verbal Recognition Memory: RM measures the ability to encode and subsequently retrieve verbal information. Secondary outcomes: number of correct-incorrect responses. Higher scores are indicative of better verbal recognition memory.

    Measured: Up to 10 minutes

  7. Change in Cognitive and Attention tasks performance (CANTAB: Rapid Visual Information Processing)

    Rapid Visual Information Processing: RVP is a sensitive tool for assessment of sustained attention. Secondary outcomes: A prime. Higher scores in this measure reflects better performance.

    Measured: Up to 10 minutes

  8. Behavioral Breath counting task: Errors

    BCT is a behavioural measure of trait mindfulness found to be reliable and correlated with self-report mindfulness. Outcome measure: number of errors.

    Measured: 20 minutes

  9. Behavioral Breath counting task: Accuracy

    BCT is a behavioural measure of trait mindfulness found to be reliable and correlated with self-report mindfulness. Outcome measure: accuracy and number of miscounts and resets.

    Measured: 20 minutes

  10. Pen and Pencil cognitive test: Colour Trails A and B

    Widely used instrument in neuropsychological assessment to measure for speed of cognitive processing and executive functioning. The direct score of both parts A and B are represented by the time taken to complete each task.

    Measured: Up to 30 minutes

  11. Pen and Pencil cognitive test: IQ Advances Progressive Matrices I and II

    This test is a nonverbal group test typically used in educational settings. It is a 60-item test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence.

    Measured: Up to 30 minutes

  12. Five Facet Mindfulness Questionnaire (FFMQ)

    This 39-item instrument is based on a factor analytic study of five independently developed mindfulness questionnaires. The analysis yielded five factors that appear to represent elements of mindfulness as it is currently conceptualized. The five facets are observing (8 items), describing (8 items), acting with awareness (8 items), non-judging of inner experience (8 items), and non-reactivity to inner experience (7 items). Scores for each subscales are calculated as the mean of the items, ranging from 1 to 5. Total FFMQ score is the mean of all the subscales, ranging 1-5.

    Measured: Past one month

  13. Change in Subjective measures of Sleep quality: Dysfunctional Beliefs and Attitudes about Sleep

    Dysfunctional Beliefs and Attitudes about Sleep (DBAS) is a 30-item self reported questionnaire to measure people's beliefs and attitudes about their personal sleep situations. Items are ranked from 0, strongly disagree, to 10, strongly agree. Total score is mean of all questions, with a higher score representing more dysfunctional beliefs and attitude about sleep.

    Measured: Past one month

  14. Change in Subjective measures of Sleep quality: Pre-Sleep Arousal,

    Pre-Sleep Arousal, PSA is a 16-item self report questionnaire having both cognitive and somatic dimensions of arousal. Scores on each subscale range from 8-40 (sum of individual answers); high scores on both subscale indicate more arousal. The Cronbach alpha of this scale was .88 and test-retest reliability is .72.

    Measured: Past one month

  15. Change in Subjective measures about mood, anxiety and quality of life: State Trait Anxiety Inventory

    State Trait Anxiety Inventory (STAI) has 40 items, 20 items allocated to each of the State-Anxiety (questions 1-8) and Trait-Anxiety (questions 9-16) subscales, each ranging from 20 to 80. It is a self-report questionnaires to indicate the presence and severity of current symptoms of anxiety and a generalized propensity to be anxious. Higher scores are positively correlated with higher levels of anxiety.

    Measured: Past year

  16. Change in Subjective measures about mood, anxiety and quality of life: Beck's Depression Inventory,

    Beck's Depression Inventory (BDI-II) is a 21- item questionnaire that evaluates the severity of depressive mood states. Each item is rated between 0 (no symptom impact) and 3 (maximum symptom impact) with a maximum score of 63. Two domains are evaluated: the cognitive-affective (questions 1-13, ranging from 0 to 39) and somatic domains (questions 14-21, ranging from 0 to 24). Higher scores in both subscales represent lower mood and more depressive symptoms.

    Measured: Up to last year

  17. Change in Subjective measures about mood, anxiety and quality of life: Short-Form 36

    Short-Form 36 (SF-36) is a 36-item self-report survey of health, including physical and mental health, with 8 scaled scores, each ranging from a minimum of 0 to max 100. Total score is the mean of all the subscales.

    Physical functioning : 10 items; Role functioning/physical : 4 items; Role emotional: 3 items; Energy/fatigue: 4 items; Mental Health: 5 items; Social functioning: 2 items; Body pain: 2 items; General health : 5 items; Reported health transition: 1 item.

    Measured: Up to last year

  18. Polysomnography: objective changes in total sleep time (TST)

    Polysomnography is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. It will be performed at night, at the convenience of the participants' home. Total sleep time reflects the amount of time participants were effectively sleeping while in bed, without periods of wakefulness.

    This objective measure of participants total sleep time will judge sleep quality against the subjective measures obtained through the sleep questionnaires.

    Measured: One night

  19. Actiwatch: objective changes in total sleep time (TST)

    Wrist-worn actigraphy is a convenient and reliable way to monitor sleep. Total sleep time reflects the amount of time participants were effectively sleeping while in bed, without periods of wakefulness, on average over seven nights of recording.

    This objective measure of participants total sleep time will judge sleep quality against the subjective measures obtained through the sleep questionnaires.

    Measured: One week

  20. Change in oxygen levels during sleep

    A Pulse Oximetry (SPO device from Somnotouch RESP, SomnoMedics) will be clipped at the end of participants' finger overnight together with the PSG recording, pre and post intervention, to measure peripheral capillary oxygen saturation changes.

    When compared with PSG and Actiwatch measures, oxygen levels can provide additional information about sleep quality. A decrease in oxygen level is often linked to sleep disorders like obstructive sleep apnea.

    Measured: One night

  21. Heart rate during sleep

    The Pulse Oximetry used for measuring oxygen levels for outcome 31 can also provide information about heart rate during sleep. Heart rate will be recorded for a full night before and after the intervention, together with PSG. Heart rate for adults during sleep varies widely across individuals, usually between 40-100 beats per minute.

    Measured: One night

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start1 Aug 2018
  3. Primary completion1 Oct 2020
  4. Study completion10 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03677726
Sponsor's protocol ID
2017/2830
Acronym
MIST
Status last verified
Jun 2021
First submitted
13 Aug 2018
Last updated
15 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Preliminary data to inform design of future studies.

Publications

  • 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.

    PubMed 29709625

  • 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.

    PubMed 30294387

  • 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.

    PubMed 24899757

  • 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.

    PubMed 20438143

  • 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.

    PubMed 24366271

  • 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.

    PubMed 23814339

  • 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.

    PubMed 35896519

  • 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.

    PubMed 34193328

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Therapy for Insomnia and Sleep Hygiene Education Exercise Program in people with Sleep Initiation and Maintenance Disorders and Cognitive Aging, run by Singapore General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Subjective measures of Sleep quality: Pittsburgh Sleep Quality Index Score (time frame: Up to one month). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03677726, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.

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