HIV InfectionsNCT00692965
Sleep Quality and Presence of Sleep Disordered Breathing
An observational study of HIV Infections and Sleep, run by University of Florida.
Trial summary
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Infections, Sleep
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jun 2009
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected, inner city ambulatory African-American population,aged 50 years and older
Who may be able to join
- African American
- Aged 50 years and older
- HIV infected
- Receiving HIV care at the Boulevard Comprehensive Care Clinic, Duval County Health Department
Who cannot join
- Patients refusing to fill out the questionnaires
- Patients less than 50 years old
- Non-African Americans
- Persons not receiving care at the Boulevard Comprehensive Care Clinic
About this study
Official title: Sleep Quality and Presence of Sleep Disordered Breathing In An Inner City African American HIV Infected Population Aged 50 Years and Older
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older.
Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.
Read the detailed description
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. A secondary objective is to investigate possible relationships between sleep quality and aspects of a patient's medical history including BMI, CD4 count, HIV viral load, history of substance abuse, psychiatric disorders, concurrent medical conditions, current HIV medications and HIV medication compliance.
Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.
- Conditions
- HIV Infections, Sleep
- Keywords
- HIV, Sleep Quality, Sleep apnea, Berlin Questionnaire, Pittsburgh Sleep Quality Index
- Medical subject headings
- HIV Infections, Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older.
Measured: 10-20 minutes to complete surveys
Secondary outcomes (1)
Investigate possible relationships between sleep quality and aspects of a patient's medical history
Measured: a single chart review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Supriya Mannepalli, MD, Principal investigator, University of FloridaAkram Khan, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692965
- Sponsor's protocol ID
- J-51-2008
- Status last verified
- Aug 2012
- First submitted
- 4 Jun 2008
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rubinstein ML, Selwyn PA. High prevalence of insomnia in an outpatient population with HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Nov 1;19(3):260-5. doi: 10.1097/00042560-199811010-00008.
PubMed 9803968Meissner HH, Riemer A, Santiago SM, Stein M, Goldman MD, Williams AJ. Failure of physician documentation of sleep complaints in hospitalized patients. West J Med. 1998 Sep;169(3):146-9.
PubMed 9771152Perkins DO, Leserman J, Stern RA, Baum SF, Liao D, Golden RN, Evans DL. Somatic symptoms and HIV infection: relationship to depressive symptoms and indicators of HIV disease. Am J Psychiatry. 1995 Dec;152(12):1776-81. doi: 10.1176/ajp.152.12.1776.
PubMed 8526245Cohen FL, Ferrans CE, Vizgirda V, Kunkle V, Cloninger L. Sleep in men and women infected with human immunodeficiency virus. Holist Nurs Pract. 1996 Jul;10(4):33-43. doi: 10.1097/00004650-199607000-00007.
PubMed 8717996Nokes KM, Kendrew J. Sleep quality in people with HIV disease. J Assoc Nurses AIDS Care. 1996 May-Jun;7(3):43-50. doi: 10.1016/S1055-3290(96)80076-8.
PubMed 8816356Norman SE, Chediak AD, Kiel M, Cohn MA. Sleep disturbances in HIV-infected homosexual men. AIDS. 1990 Aug;4(8):775-81. doi: 10.1097/00002030-199008000-00009.
PubMed 2261133Robbins JL, Phillips KD, Dudgeon WD, Hand GA. Physiological and psychological correlates of sleep in HIV infection. Clin Nurs Res. 2004 Feb;13(1):33-52. doi: 10.1177/1054773803259655.
PubMed 14768766Phillips KD, Sowell RL, Boyd M, Dudgeon WD, Hand GA; Mind-Body Research Group. Sleep quality and health-related quality of life in HIV-infected African-American women of childbearing age. Qual Life Res. 2005 May;14(4):959-70. doi: 10.1007/s11136-004-2574-0.
PubMed 16041893Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Reid S, Dwyer J. Insomnia in HIV infection: a systematic review of prevalence, correlates, and management. Psychosom Med. 2005 Mar-Apr;67(2):260-9. doi: 10.1097/01.psy.0000151771.46127.df.
PubMed 15784792Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
PubMed 10507956
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality and Presence of Sleep Disordered Breathing In An Inner City African American HIV Infected Population Aged 50 Years and Older
- ClinicalTrials.gov ID
- NCT00692965
- Acronym / sponsor ID
- J-51-2008
- Conditions
- HIV Infections, Sleep
- Keywords
- HIV, Sleep Quality, Sleep apnea, Berlin Questionnaire, Pittsburgh Sleep Quality Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Jun 2008 (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 our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older.
Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.
Detailed description
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. A secondary objective is to investigate possible relationships between sleep quality and aspects of a patient's medical history including BMI, CD4 count, HIV viral load, history of substance abuse, psychiatric disorders, concurrent medical conditions, current HIV medications and HIV medication compliance.
Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected, inner city ambulatory African-American population,aged 50 years and older
Key inclusion criteria (4 listed)
- African American
- Aged 50 years and older
- HIV infected
- Receiving HIV care at the Boulevard Comprehensive Care Clinic, Duval County Health Department
Key exclusion criteria (4 listed)
- Patients refusing to fill out the questionnaires
- Patients less than 50 years old
- Non-African Americans
- Persons not receiving care at the Boulevard Comprehensive Care Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older.
Time frame: 10-20 minutes to complete surveys
1 secondary outcome
Investigate possible relationships between sleep quality and aspects of a patient's medical history
Time frame: a single chart review
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 27 Aug 2012.
- Background: PubMed 9803968Rubinstein ML, Selwyn PA. High prevalence of insomnia in an outpatient population with HIV infection. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Nov 1;19(3):260-5. doi: 10.1097/00042560-199811010-00008.
- Background: PubMed 9771152Meissner HH, Riemer A, Santiago SM, Stein M, Goldman MD, Williams AJ. Failure of physician documentation of sleep complaints in hospitalized patients. West J Med. 1998 Sep;169(3):146-9.
- Background: PubMed 8526245Perkins DO, Leserman J, Stern RA, Baum SF, Liao D, Golden RN, Evans DL. Somatic symptoms and HIV infection: relationship to depressive symptoms and indicators of HIV disease. Am J Psychiatry. 1995 Dec;152(12):1776-81. doi: 10.1176/ajp.152.12.1776.
- Background: PubMed 8717996Cohen FL, Ferrans CE, Vizgirda V, Kunkle V, Cloninger L. Sleep in men and women infected with human immunodeficiency virus. Holist Nurs Pract. 1996 Jul;10(4):33-43. doi: 10.1097/00004650-199607000-00007.
- Background: PubMed 8816356Nokes KM, Kendrew J. Sleep quality in people with HIV disease. J Assoc Nurses AIDS Care. 1996 May-Jun;7(3):43-50. doi: 10.1016/S1055-3290(96)80076-8.
- Background: PubMed 2261133Norman SE, Chediak AD, Kiel M, Cohn MA. Sleep disturbances in HIV-infected homosexual men. AIDS. 1990 Aug;4(8):775-81. doi: 10.1097/00002030-199008000-00009.
- Background: PubMed 14768766Robbins JL, Phillips KD, Dudgeon WD, Hand GA. Physiological and psychological correlates of sleep in HIV infection. Clin Nurs Res. 2004 Feb;13(1):33-52. doi: 10.1177/1054773803259655.
- Background: PubMed 16041893Phillips KD, Sowell RL, Boyd M, Dudgeon WD, Hand GA; Mind-Body Research Group. Sleep quality and health-related quality of life in HIV-infected African-American women of childbearing age. Qual Life Res. 2005 May;14(4):959-70. doi: 10.1007/s11136-004-2574-0.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 15784792Reid S, Dwyer J. Insomnia in HIV infection: a systematic review of prevalence, correlates, and management. Psychosom Med. 2005 Mar-Apr;67(2):260-9. doi: 10.1097/01.psy.0000151771.46127.df.
- Background: PubMed 10507956Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
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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.
Supriya Mannepalli, MD principal investigator
University of Florida
Akram Khan, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sleep, run by University of Florida.
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 4 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 27 Aug 2012. 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?
The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. (time frame: 10-20 minutes to complete surveys). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692965, which also lists 11 linked publications.
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 27 Aug 2012.