Skip to main content
Clinical Trials/NCT04242771
NCT04242771
Completed
N/A

Neurophysiological Patterns of Mindfulness Meditation for Insomnia

Beth Israel Deaconess Medical Center1 site in 1 country13 target enrollmentDecember 2, 2022
ConditionsInsomnia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Insomnia
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
13
Locations
1
Primary Endpoint
Feasibility (i.e., subject retention at initial follow-up assessment)
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2, 2022
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gloria Y. Yeh

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

  • age 20 - 50 years\*
  • 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
  • speak and understand English
  • have a smart phone for mobile app installation

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Acceptability(At completion of the 4 week program)

Study Sites (1)

Loading locations...

Similar Trials