Mindfulness Meditation for Insomnia

Beth Israel Deaconess Medical Center13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Insomnia

Interventions

MindfulnessBEHAVIORAL

Subjects practice mindfulness before bedtime

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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).

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

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.

Time frame: At one month follow up visit

Secondary Outcomes

Acceptability

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.

Time frame: At completion of the 4 week program

Data from ClinicalTrials.gov

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