HIV InfectionsDISOMETANCT05835232
Sleep Disorders and Psychophysical Well-being in HIV+ Patients
An observational study of HIV Infections, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Survey
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Valentina Delle Donne, 0630155366, valentina.delledonne1@unicatt.it
About this study
Official title: Sleep Disorders, Mental Health and Quality of Life in a Court of HIV+ Patients
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
- Being tested
- Survey
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Each participant completed an anonymous 62-item online survey.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835232
- Sponsor's protocol ID
- 5250
- Acronym
- DISOMETA
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorders, Mental Health and Quality of Life in a Court of HIV+ Patients
- ClinicalTrials.gov ID
- NCT05835232
- Acronym / sponsor ID
- DISOMETA / 5250
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- HIV diagnosis.
- Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
- Ongoing antiretroviral therapy.
- Age > 18 years.
- Native Italian speaker.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyEach participant completed an anonymous 62-item online survey. | Other | – |
Primary outcome
Sleep quality
Time frame: 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.
2 secondary outcomes
Influence of sleep quality on mental health
Time frame: 1 year
Influence of sleep quality on quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.