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OpenTrials
Completed

NCT Number: NCT04242771

Mindfulness Meditation for Insomnia

This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. age 20 - 50 years*
  • 2. chronic insomnia (defined by Diagnostic and Statistical Manual Diploma in Social Medicine, DSM-V or International Classification of Sleep Disorders - Third Edition, ICSD-3) with sleep latency >20 minutes
  • 3. speak and understand English
  • 4. have a smart phone for mobile app installation

Exclusion criteria

  • 1. sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, sleep deprivation, jet lag, etc)
  • 2. shift worker or routine night shifts
  • 3. women with pregnancy or breast feeding
  • 4. history of head trauma or surgery
  • 5. regular (defined as twice a week or more) practice of mind-body interventions
  • 6. neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.)
  • 7. current use of neurologic, psychiatric, or cardiovascular medications that have expected neuropsychiatric or cardiovascular effects (i.e., beta-blockers, hypnotics, antidepressants).

Treatment and study plan

Mindfulness

Behavioral

Subjects practice mindfulness before bedtime

Primary outcomes

  1. Feasibility (i.e., subject retention at initial follow-up assessment)

    Time frame: At one month follow up visit

    The primary metric for assessing Feasibility will be subject retention at the initial follow-up assessment. This includes the proportion of enrolled subjects that are active in the study at the initial follow-up assessment.

Secondary outcomes

  1. Acceptability

    Time frame: At completion of the 4 week program

    The primary metric for assessing Acceptability will be a self-report Acceptability questionnaire which evaluates enjoyableness, convenience, helpfulness, relevancy, odds of future use, and overall satisfaction of the program.

Other outcomes

  1. Insomnia Severity Index

    Time frame: At baseline and at the end of 4-week program

    A commonly used subjective sleep measure

  2. Polysomnogram-derived sleep onset latency

    Time frame: At baseline and at the end of 4-week program

    The amount of time it takes to fall asleep after the lights have been turned off.

  3. Polysomnogram-derived sleep efficiency

    Time frame: At baseline and at the end of 4-week program

    Sleep efficiency is the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Neurophysiological Patterns of Mindfulness Meditation for Insomnia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2020
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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