search
Back to results

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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring HIV, sleep, insomnia, yoga, music

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 17, 2010
    Last Updated
    June 22, 2010
    Sponsor
    University of California, San Francisco
    search

    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

    We'll reach out to this number within 24 hrs