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

HIV Infections Clinical Trial

— SANDMAN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441383
• Other study ID #: CHT/URC/2023/11
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• HIV Infections
• Sleep Disorder
• Sleep Wake Disorders

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