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

NCT ID: NCT06441383

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-12-01

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.

Conditions

HIV Infections; Sleep Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Pittsburgh Sleep Quality Index

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tourcoing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH Tourcoing

Tourcoing, , France

Countries

France

Other Identifiers

CHT/URC/2023/11

Identifier Type: -

Identifier Source: org_study_id