An observational study in HIV Infections, Frailty and Sleep Quality, sponsored by National Sun Yat-sen University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by National Sun Yat-sen University · Observational
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.
Design: Observational case-control (cross-sectional) study conducted at the HIV outpatient clinic, Department of Infectious Diseases, National Cheng Kung University Hospital, a tertiary referral center in Tainan, Taiwan (NCKUH IRB No. B-BR-113-044). Funding: Center for Geriatric Translational Medicine, National Sun Yat-sen University (Higher Education Sprout Project), and National Cheng Kung University Hospital (grant NCKUH-11407023). Participants are recruited by convenience sampling within predefined age strata during routine outpatient visits.
Participants: Adults aged 20 years or older living with HIV who have received ART for at least 3 months (case group), and sex-matched HIV-negative pre-exposure prophylaxis (PrEP) users attending the same clinic (control group).
Sample size: Estimated with G*Power assuming a two-sided alpha of 0.05, 80% power, a standardized effect size of 0.60 for the primary between-group comparison, and an allocation ratio of approximately 3.3:1; the minimum required sample size is 125 participants.
Procedures (approximately 20 minutes at a routine clinic visit, plus 1 week of home monitoring):
Analysis: Between-group comparisons using t tests, Mann-Whitney U tests, chi-square or Fisher's exact tests. Nested multivariable linear regression models examine associations of standardized sleep measures (ISI, ESS) with physical frailty and oral hypofunction, adjusted for demographic, lifestyle, and clinical covariates, with a sensitivity model further adjusted for depressive symptoms (HADS-D), nutritional status (MNA-SF), and cognitive function (MMSE). Exploratory bootstrap mediation analysis tests physical frailty as an indirect pathway between sleep disturbance and oral hypofunction. Domain-specific associations are examined using Firth bias-reduced logistic regression.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 130 is below the median of 200 across 731 observational studies indexed under HIV Infections.
Browse HIV Infections studies →National Sun Yat-sen University is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Adults aged 20 years or older attending the infectious disease outpatient clinic of National Cheng Kung University Hospital, a medical center in southern Taiwan, including people living with HIV receiving ART and HIV-negative adults (PrEP users).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Case group (PLWH):
Control group:
Exclusion Criteria:
Adults aged 20 years or older living with HIV who have received antiretroviral therapy (ART) for at least 3 months, recruited from the infectious disease outpatient clinic of National Cheng Kung University Hospital. Participants complete sleep, frailty (physical, oral, cognitive), and psychological assessments and wear an actigraph for 1 week.
Other: No intervention (observational assessments)
HIV-negative adults aged 20 years or older (pre-exposure prophylaxis \[PrEP\] users) attending the same infectious disease outpatient clinic, sex-matched to the PLWH group. Participants complete the same sleep, frailty, and psychological assessments and wear an actigraph for 1 week.
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.
Prevalence of oral hypofunction
Oral function evaluated using the seven-domain framework of the Japanese Society of Gerodontology: oral hygiene, masticatory function, swallowing function, occlusal force, oral dryness, tongue-lip motor function (oral diadochokinesis), and tongue pressure. Oral hypofunction is defined as impairment in at least three of the seven domains. Reported as the proportion of participants with oral hypofunction in each group.
Time frame: Baseline (single study visit)
Number of impaired oral function domains
Count of impaired domains (range 0-7) within the seven-domain oral hypofunction framework (oral hygiene, masticatory function, swallowing function, occlusal force, oral dryness, tongue-lip motor function, tongue pressure). Higher scores indicate greater oral functional impairment.
Time frame: Baseline (single study visit)
Physical frailty score (Fried frailty phenotype)
Fried frailty phenotype comprising five criteria: unintentional weight loss, self-reported exhaustion, muscle weakness (grip strength), slowness (gait speed), and low physical activity (International Physical Activity Questionnaire). Continuous score range 0-5; robust = 0, pre-frail = 1-2, frail = 3-5. Higher scores indicate greater frailty.
Time frame: Baseline (single study visit)
Insomnia severity (Insomnia Severity Index, ISI)
7-item self-report questionnaire; total score range 0-28, higher scores indicate more severe insomnia. Clinically relevant insomnia defined as ISI \>= 8.
Time frame: Baseline
Daytime sleepiness (Epworth Sleepiness Scale, ESS)
8-item self-report scale (Chinese version); total score range 0-24, higher scores indicate greater daytime sleepiness. Excessive daytime sleepiness defined as ESS \> 10.
Time frame: Baseline
Domain-specific oral hypofunction components
Proportion of participants with impairment in each of the seven oral function domains (oral hygiene, masticatory function, swallowing function, occlusal force, oral dryness, tongue-lip motor function, tongue pressure).
Time frame: Baseline
Nutritional status (Mini Nutritional Assessment-Short Form, MNA-SF)
MNA-SF total score range 0-14; lower scores indicate poorer nutritional status (0-7 malnourished, 8-11 at risk of malnutrition, 12-14 normal).
Time frame: Baseline
Physical activity (International Physical Activity Questionnaire, IPAQ)
Self-reported physical activity expressed as MET-minutes per week; used to define the low physical activity criterion of the Fried frailty phenotype.
Time frame: Baseline
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
14-item scale with anxiety and depression subscales (each 0-21); higher scores indicate more severe symptoms.
Time frame: Baseline
Cognitive function (Mini-Mental State Examination, MMSE)
MMSE total score range 0-30; higher scores indicate better cognitive function; a score \<= 23 suggests cognitive impairment.
Time frame: Baseline
Risk of obstructive sleep apnea (STOP-BANG questionnaire)
8 dichotomous items; total score range 0-8. A score \>= 3 indicates high risk of obstructive sleep apnea.
Time frame: Baseline
Multidimensional sleep health (RU-SATED composite score)
Composite sleep health score across six domains (regularity, satisfaction, alertness, timing, efficiency, duration), derived from 7 days of wrist actigraphy (ActiGraph GT9X Link) and a daily sleep diary. Each domain is scored 0 (poor) or 1 (good); total range 0-6, higher scores indicate better sleep health.
Time frame: 7 days after the baseline visit
Serum Galectin-3 level
Galectin-3 concentration measured in residual serum from routine clinical blood draws.
Time frame: Baseline
Plan to share: No — Individual participant data will not be shared publicly to protect the privacy of participants living with HIV; de-identified data may be available from the principal investigator upon reasonable request and IRB approval.
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Ran from Feb 2025 to primary completion in Apr 2026, 14 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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National Sun Yat-sen University