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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06441383
Acronym
SANDMAN
Enrollment
1100
Registered
2024-06-04
Start date
2024-07-01
Completion date
2025-12-01
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sleep Disorder

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.

Interventions

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.

Sponsors

Tourcoing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of sleep disordersat baselineThe 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

MeasureTime frameDescription
Prevalence of Obstructive Sleep Apnea-Hypopnea Syndromeat baselineThe 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 Syndromeat baselineThe International Restless Legs Syndrome (RLS) Severity Scale will identify patients with symptoms in favor of RLS.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026