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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06441383
Other study ID # CHT/URC/2023/11
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date December 1, 2025

Study information

Verified date May 2024
Source Tourcoing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1100
Est. completion date December 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France CH Tourcoing Tourcoing

Sponsors (1)

Lead Sponsor Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 at baseline
Secondary Prevalence of Restless Legs Syndrome The International Restless Legs Syndrome (RLS) Severity Scale will identify patients with symptoms in favor of RLS. at baseline
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