Mindfulness Meditation for Insomnia

Beth Israel Lahey Health

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Mindfulness

Study type: Interventional

Funder types: Other

Identifiers

NCT04242771

2019P000984

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Experimental group

Experimental group

Description:

Participants will utilize a daily sleep program available within a widely used smartphone app, which includes seven soundtracks (10-15min each) for guided mindfulness practice at bedtime. Techniques include breathing exercises, mental imagery, awareness of body and mind, and muscle and body relaxation.

Treatment:

Behavioral: Mindfulness