CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Mindfulness Based Therapy for Insomnia +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03677726
NCT03677726N/ACompleted

Improving Sleep Continuity Through Mindfulness Training for Better Cognitive Ageing.

Singapore General Hospital·interventional·Posted Sep 19, 2018·Updated Jun 15, 2021

In Brief

A clinical study evaluating Mindfulness Based Therapy for Insomnia and Sleep Hygiene Education Exercise Program for Sleep Initiation and Maintenance Disorders and Cognitive Aging. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSingapore

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2018
Enrollment StartAug 1, 2018
Primary CompletionOct 1, 2020
Study CompletionJun 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.8 years ago

Interventions

Mindfulness Based Therapy for Insomniabehavioral

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

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.