Improving Sleep and Quality of Life in Adults With HIV Disease (R&R)
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Therapy
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring HIV, sleep, insomnia, yoga, music
Eligibility Criteria
Inclusion Criteria:
- at least 18 years of age
- HIV seropositive
- current sleep disturbance
- able to speak, read, and write in English
- a phone number to maintain contact with research team
- willing to provide copy of most recent CD4 and viral load values
- willing to wear actigraph for 1 week per month for 3 months
- willing to participate in group intervention sessions 3 times per week for 8 weeks
Exclusion Criteria:
- pregnancy
- psychiatric diagnosis, such as schizophrenia, dementia, bipolar disorder (depression not excluded)
- sleep disorder diagnosis, such as apnea or narcolepsy (insomnia not excluded)
- current yoga practice
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Yoga
Music Therapy
Arm Description
Outcomes
Primary Outcome Measures
self-reported sleep disturbance
Secondary Outcome Measures
actigraphic estimates of sleep quality and quantity
self-reported well-being
Full Information
NCT ID
NCT01073423
First Posted
February 17, 2010
Last Updated
June 22, 2010
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01073423
Brief Title
Improving Sleep and Quality of Life in Adults With HIV Disease
Acronym
R&R
Official Title
Improving Sleep and Quality of Life in Adults With HIV Disease: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if yoga or music therapy can improve the sleep of adults with HIV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
HIV, sleep, insomnia, yoga, music
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Title
Music Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
1-hour music therapy sessions, administered in group format 3 times per week for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
1-hour yoga sessions administered in group format 3 times per week for 8 weeks
Primary Outcome Measure Information:
Title
self-reported sleep disturbance
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
actigraphic estimates of sleep quality and quantity
Time Frame
8 weeks
Title
self-reported well-being
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 18 years of age
HIV seropositive
current sleep disturbance
able to speak, read, and write in English
a phone number to maintain contact with research team
willing to provide copy of most recent CD4 and viral load values
willing to wear actigraph for 1 week per month for 3 months
willing to participate in group intervention sessions 3 times per week for 8 weeks
Exclusion Criteria:
pregnancy
psychiatric diagnosis, such as schizophrenia, dementia, bipolar disorder (depression not excluded)
sleep disorder diagnosis, such as apnea or narcolepsy (insomnia not excluded)
current yoga practice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn A. Lee, RN, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Improving Sleep and Quality of Life in Adults With HIV Disease
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