Sleep Disorders and Psychophysical Well-being in HIV+ Patients

HIV Infections Clinical Trial

— DISOMETA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05835232
• Other study ID #: 5250
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Parasomnias
• Sleep Wake Disorders

Intervention

Other:
• Survey
Each participant completed an anonymous 62-item online survey.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Influence of sleep quality on mental health	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.	1 year
Secondary	Influence of sleep quality on quality of life	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).	1 year