Improving Sleep and Quality of Life in Adults With HIV Disease (R&R)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01073423
First received: February 17, 2010
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to see if yoga or music therapy can improve the sleep of adults with HIV.


Condition Intervention
Insomnia
Behavioral: Music Therapy
Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Sleep and Quality of Life in Adults With HIV Disease: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • self-reported sleep disturbance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • actigraphic estimates of sleep quality and quantity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • self-reported well-being [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga Behavioral: Yoga
1-hour yoga sessions administered in group format 3 times per week for 8 weeks
Active Comparator: Music Therapy Behavioral: Music Therapy
1-hour music therapy sessions, administered in group format 3 times per week for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073423

Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathryn A. Lee, RN, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Kathryn A. Lee / Associate Dean of Research, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01073423     History of Changes
Other Study ID Numbers: R&R Pilot
Study First Received: February 17, 2010
Last Updated: June 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
sleep
insomnia
yoga
music

ClinicalTrials.gov processed this record on October 19, 2014