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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00692965
Other study ID # J-51-2008
Secondary ID
Status Completed
Phase N/A
First received June 4, 2008
Last updated August 23, 2012
Start date June 2008
Est. completion date June 2009

Study information

Verified date August 2012
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.

Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.


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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- African American

- Aged 50 years and older

- HIV infected

- Receiving HIV care at the Boulevard Comprehensive Care Clinic, Duval County Health Department

Exclusion Criteria:

- 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

References & Publications (11)

Buysse 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. — View Citation

Cohen 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. — View Citation

Meissner 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. — View Citation

Netzer 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. — View Citation

Nokes KM, Kendrew J. Sleep quality in people with HIV disease. J Assoc Nurses AIDS Care. 1996 May-Jun;7(3):43-50. — View Citation

Norman SE, Chediak AD, Kiel M, Cohn MA. Sleep disturbances in HIV-infected homosexual men. AIDS. 1990 Aug;4(8):775-81. — View Citation

Perkins 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. — View Citation

Phillips 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. — View Citation

Reid S, Dwyer J. Insomnia in HIV infection: a systematic review of prevalence, correlates, and management. Psychosom Med. 2005 Mar-Apr;67(2):260-9. Review. — View Citation

Robbins 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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10-20 minutes to complete surveys No
Secondary Investigate possible relationships between sleep quality and aspects of a patient's medical history a single chart review No
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