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OpenTrials
Completed

NCT Number: NCT01534338

Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems

The primary aim of the study is to test the effect of mindfulness training on sleep parameters among older adults with insomnia symptoms

The secondary aims are to examine if changes in mindfulness meditation practice (daily log) and level of mindfulness (self-report) are associated with changes in sleep parameters, and to determine if mindfulness training is associated with in vitro biological markers of peripheral inflammation

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women (all races and ethnicities) 55 years of age and older
  • Have current problems sleeping
  • Fluent in English
  • Able to understand and provide signed informed consent
  • Willing to be randomly assigned to treatment condition

Exclusion criteria

  • Individuals currently undergoing major medical treatment such as surgery, radiation, or immunotherapy
  • Individuals living outside of a 20 mile radius from the UCLA Medical Center
  • Individuals with current substance dependence

Treatment and study plan

Mindfulness Meditation

Behavioral

Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.

Sleep Education

Behavioral

Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.

Primary outcomes

  1. Sleep

    Time frame: Within 2 weeks post-intervention

    Primary sleep outcomes to be assessed include Daily sleep diary, Pittsburgh Sleep Quality Index, Fatigue Symptom Inventory, Insomnia Severity Index, and Pre-Sleep Arousal Scale

Secondary outcomes

  1. Mindfulness

    Time frame: Within 2 weeks post-intervention

    Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice

  2. Inflammatory Biology

    Time frame: Within 2 weeks post-intervention

    Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems

Acronym: MAPS

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 16, 2012
Registry last updated
Dec 11, 2012

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.

Published trials that share one or more normalized conditions with this study.