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

NCT06441383 | Not Yet Recruiting

• 1 other identifier: CHT/URC/2023/11
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline

Secondary Outcomes (2)

• Prevalence of Obstructive Sleep Apnea-Hypopnea Syndrome

  at baseline

• Prevalence of Restless Legs Syndrome

  at baseline

Interventions

Pittsburgh Sleep Quality Index OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• PLHIV usually treated at referral centers in northern France.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tourcoing Hospital: lead

Study Sites (1)

CH Tourcoing

Tourcoing, France

Location

MeSH Terms

Conditions

HIV Infections; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)