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

Inflammation Clinical Trial

— MAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534338
• Other study ID #: MH019925
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 9, 2012
• Last updated: December 10, 2012
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Inflammation
• Parasomnias
• Sleep Disorders
• Sleep Problems

Intervention

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

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	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	Within 2 weeks post-intervention	No
Secondary	Mindfulness	Mindfulness will be assessed by self report with the Five Facet Mindfulness Questionnaire and a daily log of amount of mindfulness practice	Within 2 weeks post-intervention	No
Secondary	Inflammatory Biology	Pro-inflammatory cytokines and associated transcription markers will be assessed with in vitro assay of peripheral blood via venipuncture collected between 9am and 1130am	Within 2 weeks post-intervention	No

External Links

•   For resources on mindfulness research and practice
•   Recruitment Flyer