Mindfulness Meditation for Insomnia

Insomnia Clinical Trial

Official title:

Neurophysiological Patterns of Mindfulness Meditation for Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242771
• Other study ID #: 2019P000984
• Status: Completed
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Mindfulness
Subjects practice mindfulness before bedtime

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insomnia Severity Index	A commonly used subjective sleep measure	At baseline and at the end of 4-week program
Other	Polysomnogram-derived sleep onset latency	The amount of time it takes to fall asleep after the lights have been turned off.	At baseline and at the end of 4-week program
Other	Polysomnogram-derived sleep efficiency	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.	At baseline and at the end of 4-week program
Primary	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.	At one month follow up visit
Secondary	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.	At completion of the 4 week program