Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France (SANDMAN)

June 6, 2024 updated by: Tourcoing Hospital

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tourcoing, France
        • Ch Tourcoing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • PLHIV usually treated at referral centers in northern France.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Obstructive Sleep Apnea-Hypopnea Syndrome
Time Frame: at baseline
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
at baseline
Prevalence of Restless Legs Syndrome
Time Frame: at baseline
The International Restless Legs Syndrome (RLS) Severity Scale will identify patients with symptoms in favor of RLS.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tourcoing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHT/URC/2023/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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