Sleep Disorders and Psychophysical Well-being in HIV+ Patients

Not yet recruiting

• Conditions: HIV Infections

• Registration Number: NCT05835232
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Study First Posted: 2023-04-28
• Last Update Posted: 2023-04-28
• Study Start: 2023-05-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Influence of sleep quality on mental health	1 year	Mental health will be investigated using the Depression Anxiety Stress Scale (DASS) 21, a self-assessment instrument containing 21 useful items to investigate three constructs: depression, anxiety and stress. Each construct constitutes a specific subscale, consisting of 7 items. Each item corresponds to a statement, referring to the past week.
Influence of sleep quality on quality of life	1 year	Quality of life will be investigated using the 12-item Short-Form Health Survey (SF-12). The SF-12 investigates quality of life with 12 items: 6 items are concerned with physical health (physical functioning, physical plane limitations, physical pain, general health) and 6 items are concerned with mental health (emotional plane limitations, fatigue or lack of energy, social functioning, emotional well-being).

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy