HIV InfectionsSANDMANNCT06441383
Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France
An observational study of HIV Infections and Sleep Disorder, run by Tourcoing Hospital at 1 site in France.
Trial summary
People living with HIV (PLHIV) appear to present with sleep-related complaints more frequently than the general population, with a prevalence of 50-70%. The latest French multi-center epidemiological data are dated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sleep Disorder
- What is being tested?
- Pittsburgh Sleep Quality Index
- How many people
- 1,100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 1 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population is all adults living with HIV. The study will be offered to all PLHIV at the time of their annual specialist consultation with their infectiologist in the referring hospital centers in northern France.
Who may be able to join
- PLHIV usually treated at referral centers in northern France.
Who cannot join
- Minor patient;
- Patient with insufficient understanding of the French language, as judged by the investigator;
- Patient unable to give free and informed consent;
- Refusal to participate;
- Patient under legal protection, guardianship or curatorship;
- Pregnant and breast-feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
People living with HIV (PLHIV) appear to present with sleep-related complaints more frequently than the general population, with a prevalence of 50-70%. The latest French multi-center epidemiological data are dated. The prevalence of the different types of sleep disorders, however, is poorly documented, with the literature focusing mainly on insomnia and neuropsychological disorders that can lead to sleep disorder-like symptoms, and on the impact of antiretroviral drugs in particular. However, there are other sleep disorders such as sleep apnea syndrome (SAHOS) or restless legs syndrome. SAHOS has been studied in small series of patients.
This multicenter, cross-sectional study will identify and update the functional complaints presented by PLHIV, estimate the prevalence of people at high risk of sleep apnea syndrome, and study the associated socio-demographic factors, in relation to HIV infection and antiretrovirals. This study could open up avenues for new management approaches and earlier detection of sleep disorders.
- Conditions
- HIV Infections, Sleep Disorder
- Being tested
- Pittsburgh Sleep Quality Index
- Medical subject headings
- HIV Infections, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pittsburgh Sleep Quality IndexOther
The the Pittsburg Sleep Quality Index (PSQI) questionnaire is a standardized tool for the subjective assessment of sleep. Sleep is described according to 7 components: subjective sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disorders, medication use and daytime dysfunction. The sum of the scores for these 7 components gives an overall score of 21 points maximum.
The presence of sleep disorders will be defined according to the results of the PSQI, with a value above 5 defining the presence of sleep disorders.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disorders
The presence of sleep disorders will be defined according to the results of the Pittsburg Sleep Quality Index (PSQI), with a value greater than 5 defining the presence of sleep disorders.
Measured: at baseline
Secondary outcomes (2)
Prevalence of Obstructive Sleep Apnea-Hypopnea Syndrome
The Berlin score defines the signs suggestive of Obstructive Sleep Apnea-Hypopnea Syndrome. A score ≥ 2 positive categories will define a high risk of Obstructive Sleep Apnea-Hypopnea Syndrome
Measured: at baseline
Prevalence of Restless Legs Syndrome
The International Restless Legs Syndrome (RLS) Severity Scale will identify patients with symptoms in favor of RLS.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (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.
- 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
- Cross-sectional
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441383
- Sponsor's protocol ID
- CHT/URC/2023/11
- Acronym
- SANDMAN
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France
- ClinicalTrials.gov ID
- NCT06441383
- Acronym / sponsor ID
- SANDMAN / CHT/URC/2023/11
- Conditions
- HIV Infections, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Jun 2024 (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.
People living with HIV (PLHIV) appear to present with sleep-related complaints more frequently than the general population, with a prevalence of 50-70%. The latest French multi-center epidemiological data are dated. The prevalence of the different types of sleep disorders, however, is poorly documented, with the literature focusing mainly on insomnia and neuropsychological disorders that can lead to sleep disorder-like symptoms, and on the impact of antiretroviral drugs in particular. However, there are other sleep disorders such as sleep apnea syndrome (SAHOS) or restless legs syndrome. SAHOS has been studied in small series of patients.
This multicenter, cross-sectional study will identify and update the functional complaints presented by PLHIV, estimate the prevalence of people at high risk of sleep apnea syndrome, and study the associated socio-demographic factors, in relation to HIV infection and antiretrovirals. This study could open up avenues for new management approaches and earlier detection of sleep disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is all adults living with HIV. The study will be offered to all PLHIV at the time of their annual specialist consultation with their infectiologist in the referring hospital centers in northern France.
Key inclusion criteria (1 listed)
- PLHIV usually treated at referral centers in northern France.
Key exclusion criteria (6 listed)
- Minor patient;
- Patient with insufficient understanding of the French language, as judged by the investigator;
- Patient unable to give free and informed consent;
- Refusal to participate;
- Patient under legal protection, guardianship or curatorship;
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 |
|---|---|---|
| Pittsburgh Sleep Quality IndexThe the Pittsburg Sleep Quality Index (PSQI) questionnaire is a standardized tool for the subjective assessment of sleep. Sleep is described according to 7 components: subjective sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disorders, medication use and daytime dysfunction. The sum of the scores for these 7 components gives an overall score of 21 points maximum. The presence of sleep disorders will be defined according to the results of the PSQI, with a value above 5 defining the presence of sleep disorders. | Other | – |
Primary outcome
Prevalence of sleep disorders
Time frame: at baseline
The presence of sleep disorders will be defined according to the results of the Pittsburg Sleep Quality Index (PSQI), with a value greater than 5 defining the presence of sleep disorders.
2 secondary outcomes
Prevalence of Obstructive Sleep Apnea-Hypopnea Syndrome
Time frame: at baseline
Prevalence of Restless Legs Syndrome
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Sleep Disorder, run by Tourcoing Hospital at 1 site in France.
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 1 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 7 Jun 2024. 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sleep disorders (time frame: at baseline). 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 7 Jun 2024.