HIV InfectionsNCT07880054
Sleep Quality and Frailty Among People Living With HIV
An observational study of HIV Infections and Frailty, run by National Sun Yat-sen University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Frailty, Sleep Quality
- Type of treatment
- Pill or oral medicine
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Feb 2025to 29 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- Case group (PLWH):
- Aged 20 years or older
- Diagnosed with HIV infection
- Receiving antiretroviral therapy (ART) for at least 3 months
- Control group:
- Aged 20 years or older
- HIV-negative (e.g., pre-exposure prophylaxis [PrEP] users followed at the same clinic)
Who cannot join
- Pregnancy
- Unstable medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sleep Quality on Frailty Among People Living With HIV: A Case-Control Study
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.
Read the detailed description
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):
- Demographic and clinical data, including medical records and laboratory data (nadir and recent CD4 count, HIV viral load, time since HIV diagnosis, ART).
- Sleep questionnaires: Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and STOP-BANG.
- Psychological, nutritional, and cognitive measures: Hospital Anxiety and Depression Scale (HADS), Mini Nutritional Assessment-Short Form (MNA-SF), Mini-Mental State Examination (MMSE), and an eye-tracking-based cognitive assessment.
- Physical frailty (Fried frailty phenotype): unintentional weight loss, self-reported exhaustion, grip strength, gait speed, and physical activity (International Physical Activity Questionnaire, IPAQ).
- Oral function using the seven-domain oral hypofunction framework of the Japanese Society of Gerodontology: oral hygiene, masticatory function, swallowing function, occlusal force, oral dryness, tongue-lip motor function (oral diadochokinesis /pa/, /ta/, /ka/), and tongue pressure (Iowa Oral Performance Instrument). Oral hypofunction is defined as impairment in at least three domains.
- Multidimensional sleep health (RU-SATED) measured with wrist actigraphy (ActiGraph GT9X Link) worn for 1 week together with a daily sleep diary.
- Blood: residual specimens from routine blood draws are used to measure serum Galectin-3; no additional blood is drawn.
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.
- Conditions
- HIV Infections, Frailty, Sleep Quality, Oral Frailty
- Being tested
- No intervention (observational assessments)
- Keywords
- people living with HIV, oral hypofunction, physical frailty, insomnia, daytime sleepiness, sleep health, RU-SATED, actigraphy, tongue pressure, nutritional status, Galectin-3, antiretroviral therapy, aging
- Medical subject headings
- HIV Infections, Frailty, Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational assessments)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV (PLWH) | 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. Receives: Other: No intervention (observational assessments) | |
| HIV-negative controls | 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. Receives: Other: No intervention (observational assessments) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (single study visit)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days after the baseline visit
Serum Galectin-3 level
Galectin-3 concentration measured in residual serum from routine clinical blood draws.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Feb 2025
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Responsible party
- Sponsor
- Investigators
- Yen-Chin Chen, RN, PhD, Principal investigator, National Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880054
- Sponsor's protocol ID
- B-BR-113-044
- Other IDs
- NCKUH-11407023
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Quality on Frailty Among People Living With HIV: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07880054
- Acronym / sponsor ID
- B-BR-113-044
- Conditions
- HIV Infections, Frailty, Sleep Quality, Oral Frailty
- Keywords
- people living with HIV, oral hypofunction, physical frailty, insomnia, daytime sleepiness, sleep health, RU-SATED, actigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- National Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- National Cheng-Kung University Hospital
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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):
- Demographic and clinical data, including medical records and laboratory data (nadir and recent CD4 count, HIV viral load, time since HIV diagnosis, ART).
- Sleep questionnaires: Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and STOP-BANG.
- Psychological, nutritional, and cognitive measures: Hospital Anxiety and Depression Scale (HADS), Mini Nutritional Assessment-Short Form (MNA-SF), Mini-Mental State Examination (MMSE), and an eye-tracking-based cognitive assessment.
- Physical frailty (Fried frailty phenotype): unintentional weight loss, self-reported exhaustion, grip strength, gait speed, and physical activity (International Physical Activity Questionnaire, IPAQ).
- Oral function using the seven-domain oral hypofunction framework of the Japanese Society of Gerodontology: oral hygiene, masticatory function, swallowing function, occlusal force, oral dryness, tongue-lip motor function (oral diadochokinesis /pa/, /ta/, /ka/), and tongue pressure (Iowa Oral Performance Instrument). Oral hypofunction is defined as impairment in at least three domains.
- Multidimensional sleep health (RU-SATED) measured with wrist actigraphy (ActiGraph GT9X Link) worn for 1 week together with a daily sleep diary.
- Blood: residual specimens from routine blood draws are used to measure serum Galectin-3; no additional blood is drawn.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with HIV (PLWH) | – | Other: No intervention (observational assessments)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. |
| HIV-negative controls | – | 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (7 listed)
- Aged 20 years or older
- Diagnosed with HIV infection
- Receiving antiretroviral therapy (ART) for at least 3 months
- Aged 20 years or older
- HIV-negative (e.g., pre-exposure prophylaxis [PrEP] users followed at the same clinic)
Key exclusion criteria (2 listed)
- Pregnancy
- Unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | HIV-negative controls, People living with HIV (PLWH) |
Primary outcome
Prevalence of oral hypofunction
Time frame: Baseline (single study visit)
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.
Number of impaired oral function domains
Time frame: Baseline (single study visit)
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.
Physical frailty score (Fried frailty phenotype)
Time frame: Baseline (single study visit)
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.
10 secondary outcomes
Insomnia severity (Insomnia Severity Index, ISI)
Time frame: Baseline
Daytime sleepiness (Epworth Sleepiness Scale, ESS)
Time frame: Baseline
Domain-specific oral hypofunction components
Time frame: Baseline
Nutritional status (Mini Nutritional Assessment-Short Form, MNA-SF)
Time frame: Baseline
Physical activity (International Physical Activity Questionnaire, IPAQ)
Time frame: Baseline
Anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Baseline
Cognitive function (Mini-Mental State Examination, MMSE)
Time frame: Baseline
Risk of obstructive sleep apnea (STOP-BANG questionnaire)
Time frame: Baseline
Multidimensional sleep health (RU-SATED composite score)
Time frame: 7 days after the baseline visit
Serum Galectin-3 level
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Chin Chen, RN, PhD principal investigator
National Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Frailty, run by National Sun Yat-sen University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of oral hypofunction (time frame: Baseline (single study visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.