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The investigation of effectiveness of mindfulness meditation on sleep quality in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

The investigation of effectiveness of mindfulness meditation on sleep quality in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000086460
Enrollment
45
Registered
2025-01-28
Start date
2025-08-01
Completion date
2025-10-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Unrefreshing sleep is the hallmark of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), affecting up to 95% of patients. Sleep is defined by coordinated cortical and cardiac oscillations reflecting communication between the central (CNS) and autonomic nervous systems (ANS), which can be modulated by mindfulness meditation. There is a growing interest in the effectiveness of mindfulness meditation for sleep disturbed populations. Mindfulness meditation may help improve sleep quality in ME/CFS patients. This study is designed to evaluate the effect of an 8-week mindfulness meditation on sleep quality in patients with ME/CFS and understand the underlying neurobiological process of meditation in patients with ME/CFS using self-report questionnaires and neuroimaging measures.

Interventions

A meditation voice recording will be developed specifically for this study. Participants will practice mindfulness meditation 10 minutes a day, 7 days a week for eight weeks. Participants are required to practice mindfulness meditation every day at the same time to ensure consistency following a voice recording instruction presented via a website and record their practices in a journal. If participants cannot make it consistent every day, they can report any deviations to the planned schedule. T

A meditation voice recording will be developed specifically for this study. Participants will practice mindfulness meditation 10 minutes a day, 7 days a week for eight weeks. Participants are required to practice mindfulness meditation every day at the same time to ensure consistency following a voice recording instruction presented via a website and record their practices in a journal. If participants cannot make it consistent every day, they can report any deviations to the planned schedule. The mindfulness meditation includes breath work, body scan, visualization, and positive affirmation. Researcher will check in with the participant individually via phone on weekly basis to assist with any difficulties while doing intervention by themselves at home or answer any questions participants might have.

Sponsors

University of the Sunshine Coast
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

• Persons aged 18-65 years. • Meet ME/CFS definition based on Canadian Concensus Criteria (CCC) and being diagnosed by a medical professional. • Meditation naive, have little to no prior experience or exposure to meditation practices. Considered beginners or novices in the realm of meditation and may not have any formal training or understanding of meditation techniques. • Participants must be able to understand Research Project Information Sheet (RPIS) and provide written informed consent on the Participant Informed Consent Form (PICF). • Proficient in spoken and written English. • Have access to a computer at home, in a private space to undergo the mindfulness meditation. • Participants must be available to attend the Thompson Institute (TI) for 2 MRI scans. • Participants must be able to attend 60-minute guided meditation class weekly either at the TI or on Zoom. • Participants must be able to undergo MRI, and tolerate the mindfulness meditation therapy. Tolerability to the technique will be assessed by the researcher, which will include a short training of the technique while attending the TI and as an extra check will include a short interview during the 2nd visit to assess how they are responding to the technique. • Have basic computer skills and are able to learn and follow new instructions to engage in the technique.

Exclusion criteria

• With diagnosed obstructive sleep apnoea (OSA) • Pregnant • With severe intellectual or mental impairment preventing them from fully understanding the study to give consent • With a known neurological disorder • Who cannot read and communicate in English • Recruited by a relationship with the supervisory team or where a conflict of interest exists • With alcohol or substance related disorder • With BMI >35

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026