Effects of Surgery on Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea

Condition(s) studied

Investigational drug(s) / intervention(s)

Upper 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.

Non-surgical management: 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 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.

Eligibility

Primary outcome measure(s)

• 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).

Trial sites (1)

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