InsomniaR&RNCT01073423
Improving Sleep and Quality of Life in Adults With HIV Disease
A study testing Music Therapy and Yoga in people with Insomnia, run by University of California, San Francisco.
Trial summary
The purpose of this study is to see if yoga or music therapy can improve the sleep of adults with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Music Therapy and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
1-hour music therapy sessions, administered in group format 3 times per week for 8 weeks.
YogaBehavioural
1-hour yoga sessions administered in group format 3 times per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Not described Receives: Behavioral: Yoga |
| Music Therapy | Active comparator | Not described Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported sleep disturbance
Measured: 8 weeks
Secondary outcomes (2)
actigraphic estimates of sleep quality and quantity
Measured: 8 weeks
self-reported well-being
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Kathryn A. Lee, RN, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073423
- Sponsor's protocol ID
- R&R Pilot
- Acronym
- R&R
- Status last verified
- Jun 2010
- First submitted
- 17 Feb 2010
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep and Quality of Life in Adults With HIV Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT01073423
- Acronym / sponsor ID
- R&R / R&R Pilot
- Conditions
- Insomnia
- Keywords
- HIV, sleep, insomnia, yoga, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if yoga or music therapy can improve the sleep of adults with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga |
| Music Therapy | Active comparator | Behavioral: Music Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Therapy1-hour music therapy sessions, administered in group format 3 times per week for 8 weeks. | Behavioural | Music Therapy |
| Yoga1-hour yoga sessions administered in group format 3 times per week for 8 weeks | Behavioural | Yoga |
Primary outcome
self-reported sleep disturbance
Time frame: 8 weeks
2 secondary outcomes
actigraphic estimates of sleep quality and quantity
Time frame: 8 weeks
self-reported well-being
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn A. Lee, RN, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy and Yoga in people with Insomnia, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported sleep disturbance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2010.