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

Not yet recruiting

• Conditions: Sleep Disorder; HIV Infections

• Registration Number: NCT06441383
• Lead Sponsor: Tourcoing Hospital

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-28
• Study First Posted: 2024-06-04
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Study Start: 2024-07-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of sleep disorders	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CH Tourcoing; 🇫🇷 Tourcoing, France