OSA - Obstructive Sleep ApneaNCT07880067
Effects of Surgery on Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea
An observational study of OSA - Obstructive Sleep Apnea and Dysphagia, run by National Sun Yat-sen University at 1 site in Taiwan.
Trial summary
Dysphagia is a commonly reported complaint among patients with obstructive sleep apnea (OSA), particularly those who have undergone upper-airway (oropharyngeal) surgery. However, how surgical treatment for OSA affects swallowing function and oral function (oral frailty) remains unclear. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- OSA - Obstructive Sleep Apnea, Dysphagia, Oral Frailty
- What is being tested?
- Upper airway surgery for OSA and Non-surgical management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jun 2026to 31 Dec 2028
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with moderate-to-severe obstructive sleep apnea attending the sleep medicine outpatient clinic of Kaohsiung Armed Forces General Hospital, Taiwan, who intend to receive next-step treatment (surgical or non-surgical).
Who may be able to join
- Diagnosed by a physician with moderate-to-severe obstructive sleep apnea (apnea-hypopnea index >= 15 events/hour)
- Aged 20 years or older
- Willing to receive next-step treatment for obstructive sleep apnea
- Willing to participate and provides written informed consent
Who cannot join
- Diagnosed with central sleep apnea
- Neuromuscular disease (e.g., stroke, Parkinson's disease)
- Diagnosed with oral cancer and currently receiving oral treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Armed Forces General Hospital
Kaohsiung City, 802
About this study
Official title: The Effects of Surgery on Improving Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea (OSA): A Prospective Cohort Study
Dysphagia is a commonly reported complaint among patients with obstructive sleep apnea (OSA), particularly those who have undergone upper-airway (oropharyngeal) surgery. However, how surgical treatment for OSA affects swallowing function and oral function (oral frailty) remains unclear.
This prospective cohort study recruits adults with moderate-to-severe OSA from the sleep medicine clinic of Kaohsiung Armed Forces General Hospital, Taiwan. Participants choose their own treatment as part of routine care; the study does not assign or influence treatment. Participants who undergo OSA surgery form the surgery group, and those who receive non-surgical treatment (e.g., CPAP) or no treatment form the non-surgical group. Swallowing difficulty (EAT-10) and oral frailty (seven oral hypofunction indicators) are assessed before treatment and at 1, 3, and 6 months after treatment.
Read the detailed description
Background: Obstructive sleep apnea (OSA) is one of the most prevalent non-communicable diseases worldwide. Impaired swallowing reflex, pharyngeal sensory deficits and dysphagia have been reported in 16-78% of patients with OSA, and oropharyngeal surgery (e.g., uvulopalatopharyngoplasty) may further alter swallowing physiology. Oral frailty, a cluster of declines in oral function, is associated with dysphagia, physical frailty and mortality, yet it has not been examined in surgically treated OSA patients.
Design: Prospective observational cohort study. This registration covers Phase 2 of a two-phase project; Phase 1 is a separate retrospective analysis of Taiwan's National Health Insurance Research Database (2001-2020) comparing the incidence of dysphagia between OSA patients and matched non-OSA controls.
Participants: Adults aged 20 years or older with moderate-to-severe OSA (apnea-hypopnea index >= 15 events/hour) who intend to receive next-step treatment. The target sample size is 450 (surgery group 225; non-surgical/no-treatment group 225), estimated with G*Power (exact test; p1 = 0.16, p2 = 0.05, power = 0.95, allocation ratio 1:1).
Exposure: Surgical treatment chosen by the patient, such as radiofrequency reduction of the soft palate or tongue base, palatine tonsillectomy, uvulopalatopharyngoplasty (UPPP), CO2 laser-assisted uvulopalatoplasty (LAUP), transoral robotic surgery (TORS) and other upper-airway procedures. Treatment decisions are made by patients and their physicians; the study only records the treatment received.
Assessments (T0 before treatment; T1, T2 and T3 at 1, 3 and 6 months after treatment): Eating Assessment Tool-10 (EAT-10); oral frailty assessed by the seven oral hypofunction indicators (Minakuchi et al., 2018): tongue coating index, Saxon test, oral diadochokinesis (/pa/, /ta/, /ka/), number of natural teeth, tongue pressure (Iowa Oral Performance Instrument), self-reported masticatory ability, and the repetitive saliva swallowing test (RSST). Covariates include demographics, anthropometrics, blood pressure, comorbidities, smoking, alcohol use, exercise, prior oropharyngeal surgery, fatigue and OSA severity (AHI).
Analysis: Descriptive statistics will summarize treatment choices and baseline characteristics; between-group differences will be compared; repeated-measures analysis will compare changes in dysphagia and oral frailty between the surgery and non-surgical groups over 6 months.
- Conditions
- OSA - Obstructive Sleep Apnea, Dysphagia, Oral Frailty
- Being tested
- Upper airway surgery for OSA, Non-surgical management
- Keywords
- obstructive sleep apnea, oral frailty, oral hypofunction, dysphagia, swallowing, upper airway surgery, uvulopalatopharyngoplasty, tongue pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper airway surgery for OSAProcedure or surgery
Upper-airway surgical procedures chosen by the patient as part of routine care, including radiofrequency reduction of the soft palate or tongue base, palatine tonsillectomy, partial glossectomy, uvulopalatopharyngoplasty (UPPP), CO2 laser-assisted uvulopalatoplasty (LAUP), transoral robotic surgery (TORS) and related procedures. Not assigned by the study.
Non-surgical managementOther
CPAP or other non-surgical management (e.g., oral appliance, weight control), or no treatment, as chosen by the patient as part of routine care. Not assigned by the study.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical group | Adults with moderate-to-severe OSA who choose non-surgical treatment (e.g., CPAP) or no treatment as part of routine care. Treatment is not assigned by the study. Receives: Other: Non-surgical management | |
| Surgery group | Adults with moderate-to-severe OSA who elect upper-airway surgery as part of routine care (e.g., radiofrequency reduction of the palate or tongue base, tonsillectomy, UPPP, LAUP, TORS). Treatment is not assigned by the study. Receives: Procedure: Upper airway surgery for OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in swallowing difficulty measured by the Eating Assessment Tool-10 (EAT-10)
Chinese version of the EAT-10; 10 self-rated items scored 0 (no problem) to 4 (severe problem); total score 0-40, with higher scores indicating worse swallowing difficulty. A total score of 3 or more indicates swallowing problems.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Change in oral frailty (number of oral hypofunction indicators)
Number of the seven oral hypofunction indicators met (Minakuchi et al., 2018): poor oral hygiene, oral dryness, reduced occlusal force, reduced tongue-lip motor function, reduced tongue pressure, decreased masticatory function and deteriorated swallowing function. Range 0-7; meeting 3 or more indicators defines oral frailty (oral hypofunction).
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Secondary outcomes (7)
Tongue pressure
Maximum tongue pressure (kPa) measured with the Iowa Oral Performance Instrument (IOPI); participants press the bulb against the palate for 7 seconds, three trials with 30-second rests, mean value used. Less than 30 kPa indicates low tongue pressure.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Tongue coating index
Tongue coating index (TCI, %); 50% or higher indicates poor oral hygiene.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Oral dryness (Saxon test)
Saliva production measured by the Saxon test (gauze placed under the tongue for 1 minute); less than 0.1 g/min indicates oral dryness.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Oral diadochokinesis
Number of repetitions per second of the syllables /pa/, /ta/ and /ka/ over 5 seconds; fewer than 6 per second for any syllable indicates reduced tongue-lip motor function.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Number of natural teeth
Number of remaining natural teeth; fewer than 20 indicates reduced occlusal force.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Self-reported masticatory ability
Self-reported masticatory ability questionnaire; difficulty or inability to chew 4 or more listed foods indicates decreased masticatory function.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
Repetitive saliva swallowing test (RSST)
Number of voluntary saliva swallows in 30 seconds; 3 or more is considered normal.
Measured: Baseline (before treatment), and 1, 3 and 6 months after treatment
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 start12 Jun 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Armed Forces General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880067
- Sponsor's protocol ID
- KAFGHIRB114-068
- Other IDs
- 802KB114599
- 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