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NCT07880054

Sleep Quality and Frailty Among People Living With HIV

Sponsor: National Sun Yat-sen University

View on ClinicalTrials.gov

Summary

With effective antiretroviral therapy (ART), people living with HIV (PLWH) are living longer and are increasingly experiencing aging-related conditions such as frailty and sleep problems. However, most frailty research has focused on the general older population, and little is known about how sleep relates to physical and oral frailty in PLWH. This case-control study compares sleep disturbance, physical frailty, and oral hypofunction between adults living with HIV receiving ART and sex-matched HIV-negative pre-exposure prophylaxis (PrEP) users recruited from an infectious disease outpatient clinic at a medical center in southern Taiwan. The study also examines whether sleep disturbance (insomnia severity and daytime sleepiness) is associated with physical frailty and oral hypofunction, whether physical frailty represents an indirect pathway between sleep disturbance and oral hypofunction, and the roles of ART and serum Galectin-3 levels in predicting frailty among PLWH.

Official title: Effects of Sleep Quality on Frailty Among People Living With HIV: A Case-Control Study

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2025-02-25

Completion Date

2026-04-29

Last Updated

2026-10-19

Healthy Volunteers

Yes

Interventions

OTHER

No intervention (observational assessments)

No intervention is administered. All participants undergo observational assessments only: questionnaires (ISI, C-ESS, STOP-BANG, HADS), cognitive assessment (MMSE and eye tracking), grip strength and 6-meter walking speed, oral frailty assessment (teeth count, masticatory ability, oral diadochokinesis, IOPI tongue and swallowing pressure, choking), 1-week wrist actigraphy with sleep diary, and Galectin-3 measurement in residual routine blood samples.

Locations (1)

National Cheng Kung University Hospital

Tainan, Taiwan