Sleep Quality and Presence of Sleep Disordered Breathing - Full Text View

Sponsor:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00692965

Purpose

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.

Condition
HIV Infections Sleep

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Sleep Quality and Presence of Sleep Disordered Breathing In An Inner City African American HIV Infected Population Aged 50 Years and Older

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigate possible relationships between sleep quality and aspects of a patient's medical history [ Time Frame: a single chart review ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

HIV infected, inner city ambulatory African-American ppulation,aged 50 years and older

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692965

Contacts

Contact: Katherine Rogers, BSN	904-253-1261	katherine_rogers@doh.state.fl.us
Contact: Supriya Mannepalli, MD	904-253-1040	Supriya_mannepalli@doh.state.fl.us

Locations

United States, Florida
Boulevard Comprehensive Care Clinic	Recruiting
Jacksonville, Florida, United States, 32206
Contact: Katherine Rogers, BSN 904-253-1261 katherine_rogers@doh.state.fl.us
Contact: Nilmarie Guzman 904-253-1040 nilmarie_guzman@doh.state.fl.us
Principal Investigator: Supriya Mannepalli, MD
Principal Investigator: Akram Khan, MD
Sub-Investigator: Nilmarie Guzman, MD
Sub-Investigator: Michael Sands, MD
Sub-Investigator: Nilmarie Guzman, MD

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:	Supriya Mannepalli, MD	University of Florida
Principal Investigator:	Akram Khan, MD	University of Florida

More Information

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.

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.

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.

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.

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

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

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.

Phillips KD, Sowell RL, Boyd M, Dudgeon WD, Hand GA; The 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.

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.

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.

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.

Responsible Party:	University of Florida ( Supriya Mannepalli, MD )
Study ID Numbers:	J-51-2008
Study First Received:	June 4, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00692965 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

HIV
Sleep Quality
Sleep apnea
Berlin Questionnaire
Pittsburg Sleep Quality Index

Additional relevant MeSH terms:

Sleep Apnea Syndromes
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Apnea
Nervous System Diseases
Respiration Disorders
Acquired Immunodeficiency Syndrome
Sleep Disorders

Dyssomnias
Infection
Immunologic Deficiency Syndromes
Sleep Disorders, Intrinsic
Virus Diseases
Respiratory Tract Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010