OSA - Obstructive Sleep Apnea, Dysphagia, Oral Frailty
Conditions
Keywords
obstructive sleep apnea, oral frailty, oral hypofunction, dysphagia, swallowing, upper airway surgery, uvulopalatopharyngoplasty, tongue pressure
Brief 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. 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.
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.
Interventions
PROCEDUREUpper airway surgery for OSA
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.
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.
Sponsors
National Sun Yat-sen University
Kaohsiung Armed Forces General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Diagnosed with central sleep apnea * Neuromuscular disease (e.g., stroke, Parkinson's disease) * Diagnosed with oral cancer and currently receiving oral treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in swallowing difficulty measured by the Eating Assessment Tool-10 (EAT-10) | Baseline (before treatment), and 1, 3 and 6 months after treatment | 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. |
| Change in oral frailty (number of oral hypofunction indicators) | Baseline (before treatment), and 1, 3 and 6 months after treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tongue pressure | Baseline (before treatment), and 1, 3 and 6 months after treatment | 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. |
| Tongue coating index | Baseline (before treatment), and 1, 3 and 6 months after treatment | Tongue coating index (TCI, %); 50% or higher indicates poor oral hygiene. |
| Oral dryness (Saxon test) | Baseline (before treatment), and 1, 3 and 6 months after treatment | Saliva production measured by the Saxon test (gauze placed under the tongue for 1 minute); less than 0.1 g/min indicates oral dryness. |
| Oral diadochokinesis | Baseline (before treatment), and 1, 3 and 6 months after treatment | 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. |
| Number of natural teeth | Baseline (before treatment), and 1, 3 and 6 months after treatment | Number of remaining natural teeth; fewer than 20 indicates reduced occlusal force. |
| Self-reported masticatory ability | Baseline (before treatment), and 1, 3 and 6 months after treatment | Self-reported masticatory ability questionnaire; difficulty or inability to chew 4 or more listed foods indicates decreased masticatory function. |
| Repetitive saliva swallowing test (RSST) | Baseline (before treatment), and 1, 3 and 6 months after treatment | Number of voluntary saliva swallows in 30 seconds; 3 or more is considered normal. |
Countries
Taiwan
Contacts
CONTACTYen-Chin Chen, RN, PhD
CONTACTTrista Kuo, Master
Outcome results
None listed