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

June 22, 2010 updated by: University of California, San Francisco

Improving Sleep and Quality of Life in Adults With HIV Disease: A Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
self-reported sleep disturbance
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
actigraphic estimates of sleep quality and quantity
Time Frame: 8 weeks
8 weeks
self-reported well-being
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Kathryn A. Lee, RN, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

June 22, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R&R Pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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