Sleep Disorders and Psychophysical Well-being in HIV+ Patients

NCT05835232 | Unknown

• 1 other identifier: 5250
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this observational study is to investigate sleep quality in patients living with HIV+. The secondary objective is to measure the influence of sleep quality on indicators of mental health (anxiety, depression and stress) and quality of life. The main questions it aims to answer are:

• Measuring the effects of poor sleep quality on mental and physical health in HIV+ patients.
• Monitor the sleep pattern in the HIV+ population. Participants will fill out an online cross-sectional survey. The online questionnaire survey will collect:
• sociodemographic and clinical data related to HIV infection,
• sleep quality,
• mental health,
• quality of life.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  It will investigate with the Italian version of the Pittsburgh Sleep Quality Index (PSQI) the quality of sleep in HIV+ patients by assessing the reported subjective quality, latency, duration, efficiency, degree of disturbed sleep, use of sleep medications, and how much sleep-related problems affect daily routines.

  1 year

Secondary Outcomes (2)

• Influence of sleep quality on mental health

  1 year

• Influence of sleep quality on quality of life

  1 year

Interventions

Survey OTHER

Each participant completed an anonymous 62-item online survey.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We expect the majority of the HIV patient population to be male, between the ages of 40 and 65 and with a high school diploma. We expect a virologically suppressed HIV population with good adherence to antiretroviral therapy. We expect poor sleep quality and low quality of life and high symptoms of depression, anxiety and stress.

You may qualify if:

• HIV diagnosis.
• Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
• Ongoing antiretroviral therapy.
• Age \> 18 years.
• Native Italian speaker.
• Informed consent to participate in the study

You may not qualify if:

• Absence of an HIV diagnosis.
• Not being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
• Absence of ongoing antiretroviral therapy.
• Age \> 18 years.
• Not being a native Italian speaker.
• Refusal to sign informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: May 1, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)