Randomised trial of nasal surgery for fixed nasal obstruction in obstructive sleep apnoea

Abstract

Although nasal surgery has limited efficacy in obstructive sleep apnoea (OSA) treatment, some patients experience improvement. The present study tested the hypothesis that post-surgery improvement is associated with increased nasal breathing epochs. A total of 49 OSA patients (mean apnoea/hypopnoea index (AHI) 30.1+/-16.3 events x h(-1)) with symptomatic fixed nasal obstruction due to deviated septum were randomly assigned to either septoplasty (surgery group; 27 patients) or sham surgery (placebo group; 22 patients). The breathing route was examined during overnight polysomnography. All patients in the placebo group were nonresponders, whereas in the surgery group four (14.8%) patients were responders and exhibited considerable increase in nasal breathing epochs (epochs containing more than three consecutive phasic nasal signals), and 23 patients were nonresponders, presenting a modest increase in nasal breathing epochs. The change in AHI was inversely related to the change in nasal breathing epochs, with responders exhibiting among the greatest increases in nasal breathing epochs. Baseline nasal breathing epochs were positively related to per cent change in AHI. Responders had among the lowest baseline nasal breathing epochs; a cut-off value of 62.4% of total sleep epochs best separated (100% sensitivity, 82.6% specificity) responders/nonresponders. In conclusion, nasal surgery rarely treats obstructive sleep apnoea effectively. Baseline nasal breathing epochs can predict the surgery outcome.

Clinical Practice Guideline: Improving Nasal Form and Function after Rhinoplasty

“…80 However, a randomized placebo-controlled study (ie, sham surgery) of septoplasty with or without bilateral inferior turbinectomy among 49 patients with OSA did not reveal improvement in the AHI. 81 Similarly, a meta-analysis of 9 studies with 302 patients did not demonstrate improvement in the AHI (35.2 ± 22.6 to 33.5 ± 23.8, P = .69) after various forms of nasal surgery. 82 In fact, Friedman and colleagues demonstrated a postoperative increase in AHI, especially for those with mild OSA, 6 weeks following submucosal resection of the septum and inferior turbinates bilaterally.…”

Blinding in trials of interventional procedures is possible and worthwhile

“…In order to mimick the sounds, surgeons were required to talk through the procedure steps 46 , ask for instruments 47, 48 , use suction 48 or ask for a laser or other device to be activated, even though it was not used in the placebo group 49– 53 .…”

“…Many trials specifically stated that the duration of procedure in the surgical and control arms were matched, either by immitating the elements of the surgical procedure or by keeping all patients in the operation room for the same duration of time 34, 38, 45, 47, 48, 60, 61 . However, in some trials, the placebo procedure was shortened in comparison to the actual surgery because it was believed it would have been ethically unacceptable to prolong the placebo intervention 49, 55 .…”

Effect of laparoscopic Roux-en-Y gastric bypass surgery on obstructive sleep apnea in a Chinese population with obesity and T2DM

“…Moreover, 6-86 % of patients who used oral appliances have been reported to experience adverse effects, including dryness of the tongue and throat, pain in the teeth and jaw, and insomnia [7,9]. Various surgical techniques of the upper airway have been used to treat OSA, although the use of surgery for this condition remains somewhat controversial and is associated with limited and unpredictable efficacy that may diminish over the long term [10][11][12]. That is, although several treatments exist, they are often poorly tolerated or only partially alleviate the abnormalities.…”