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Sleep Disorders and Psychophysical Well-being in HIV+ Patients

Sleep Disorders, Mental Health and Quality of Life in a Court of HIV+ Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05835232
Acronym
DISOMETA
Enrollment
51
Registered
2023-04-28
Start date
2023-05-01
Completion date
2023-05-31
Last updated
2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

OTHERSurvey

Each participant completed an anonymous 62-item online survey.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep quality1 yearIt 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

MeasureTime frameDescription
Influence of sleep quality on mental health1 yearMental 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 life1 yearQuality 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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026