Improving Sleep and Quality of Life in Adults With HIV Disease

Insomnia Clinical Trial

— R&R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073423
• Other study ID #: R&R Pilot
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: June 22, 2010
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Music Therapy
1-hour music therapy sessions, administered in group format 3 times per week for 8 weeks.
• Yoga
1-hour yoga sessions administered in group format 3 times per week for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported sleep disturbance		8 weeks	No
Secondary	actigraphic estimates of sleep quality and quantity		8 weeks	No
Secondary	self-reported well-being		8 weeks	No