A Randomized Trial of Laser-assisted Uvulopalatoplasty in the Treatment of Mild Obstructive Sleep Apnea-XIYUANLU

A Randomized Trial of Laser-assisted Uvulopalatoplasty in the Treatment of Mild Obstructive Sleep Apnea-EDUCATION-XIYUANLU

Departments of Medicine and Otolaryngology, University of Western Ontario, London, Ontario, Canada

ABSTRACT

TOP

ABSTRACT

INTRODUCTION

METHODS

RESULTS

DISCUSSION

REFERENCES

Laser-assisted uvulopalatoplasty (LAUP) is an outpatient surgicaltreatment for snoring and obstructive sleep apnea (OSA), butto date, no controlled trials have been published. Forty-fivesubjects with mild OSA (apnea/hypopnea index [AHI], 10¨C27per hour) were randomized to LAUP or to no treatment (controlgroup). The AHI post-LAUP was reduced by 21% overall and to10 or less per hour in 5 of 21 subjects (24%). Four of 24 subjectsin the control group (16.7%) had an AHI of 10 or less per hourat outcome. The AHI decreased with the LAUP compared with nochange with the control group at outcome. Ten subjects (48%)reported significantly improved snoring after the LAUP. Therewas no improvement in excessive daytime sleepiness, but therewas a small improvement in quality of life (unless side effectswere included in the quality of life score). Side effects werecommon, but serious complications did not occur. LAUP surgeryis effective in some subjects with mild OSA for the treatmentof snoring, but the reduction in AHI and the level of symptomaticimprovement were minor overall.

Key Words: obstructive sleep apnea • randomized trial • laser surgery • laser-assisted uvulopalatoplasty

INTRODUCTION

TOP

BSTRACT

INTRODUCTION

METHODS

RESULTS

DISCUSSION

REFERENCES

There are a number of options for the treatment of snoring andobstructive sleep apnea (OSA). Patients with moderate to severeOSA are usually treated with nasal continuous positive airwaypressure (1). Although continuous positive airway pressure eliminatesapnea in virtually all cases, there are problems with patientacceptance of continuous positive airway pressure therapy, particularlyin patients with mild OSA. Oral appliances are safe and reasonablyeffective in patients with mild OSA, but they also representa control and not a cure (2, 3). Patients who desire a curefor their problem generally look to surgical treatment. Thetwo most common surgical procedures are uvulopalatopharyngoplasty(UPPP) and laser-assisted uvulopalatoplasty (LAUP).

Kamami developed the LAUP procedure as an alternative to UPPP(4). He first used it in patients who complained of snoringafter UPPP and who still had residual vibrating tissue on theirsoft palate (5). Subsequently, the procedure was expanded topatients who wanted their snoring treated without undergoinga major procedure under general anesthesia. Despite its widespreaduse, LAUP has not been established as an effective therapy forOSA in the setting of controlled clinical trials, and in uncontrolledtrials, the results are variable (6). Many clinicians and patientsare convinced of its effectiveness in relieving snoring basedon their personal experience, but rarely is treatment successobjectively documented. A published guideline focused on thelack of controlled studies and recommended that patients shouldbe told that the risks, benefits, and complications of the procedureare not known (7). In an update published in 2000, the authorsstated that no controlled trials were found in the peer-reviewedliterature, and they recommended that LAUP not be done for thetreatment of OSA (8). However, it could be used for the treatmentof snoring. In general, the studies published to date have beenretrospective case series or prospective precomparisons andpostcomparisons without control groups and often with incompletefollow-up. Problems with many of these studies include poorlydetailed methods and selection criteria, inadequate overnightmonitoring (before and after surgery), mainly subjective follow-up,and incompletely defined outcome criteria. Other deficienciesof this literature have been well described previously (9).

The objective of this study was to determine with a randomized,controlled trial the efficacy of LAUP in relieving OSA in patientswith mild symptomatic sleep apnea. The secondary objectiveswere to determine the effect of LAUP on symptoms of OSA, includingsnoring, daytime sleepiness, and quality of life.

METHODS

TOP

ABSTRACT

INTRODUCTION

METHODS

RESULTS

DISCUSSION

REFERENCES

Forty-five subjects who had mild OSA (apnea/hypopnea index [AHI],10.1¨C25) and complained of loud snoring were recruited.Weight, body mass index, blood pressure, and neck circumferencewere recorded at baseline. A detailed questionnaire was administeredalong with the Epworth Sleepiness Scale (10) and the CalgarySleep Apnea Quality of Life Index (SAQLI) (11). The five domainsof the SAQLI include domain A daily functioning, domain B socialinteractions, domain C emotional functioning, domain D symptoms,and domain E treatment-related symptoms (side effects and complications).Snoring intensity and frequency were rated on a modified four-pointLikert Scale (never, softly, moderately, loudly and never, rarely,sometimes, often respectively). The bed partner or householdmember rated snoring intensity (0 = none to 10 = loud) and frequency(0 = never to 10 = always) with a visual analog scale.

Using a table of random numbers, subjects were randomized toeither the LAUP group or the no-treatment group (control group).The control subjects were not offered any therapy but were offeredLAUP at the end of the study. Questionnaires, scales, and thepolysomnogram were repeated 3 months after the last LAUP procedureor 6 months after baseline in the control group. The frequencyand severity of treatment side effects and complications inthe LAUP group were recorded.

Overnight Polysomnography

A standard montage was used for polysomnography, including electroencephalogram,electro-oculogram, submental electromyogram, left and rightanterior tibialis electromyogram, electrocardiogram, thoracoabdominalmotion, oronasal airflow (thermistor), and arterial oxygen saturationwith pulse oximetry. Obstructive apneas were defined as thecessation of airflow for at least 10 seconds accompanied byongoing respiratory effort. Obstructive hypopneas were definedas a reduction in airflow of at least 50% for at least 10 secondsaccompanied by a reduction in respiratory effort. Events wereassociated with an arousal and/or an oxygen desaturation of3% and/or an associated period of bradycardia/tachycardia.

LAUP Procedure

The LAUP procedure was repeated at 1- to 2-month intervals.The end points for the LAUP procedure were (1) when the snoringwas reported to be significantly reduced or eliminated, (2)no more tissue could be safely removed, or (3) the patient refusedfurther surgery.

Subjects received preoperative pain medication. Topical anesthesiawas applied liberally, and lidocaine was injected into the uvulaand soft palate. A series of full-thickness vertical trencheswere created with the CO₂ laser on the free edge of the softpalate on either side of the uvula. The uvula was shortenedand thinned to a fraction of its former size. The edge of thesoft palate was also reduced. The tonsils were not treated.A backstop on the laser attachment was used to prevent injuryto the posterior pharyngeal wall. The laser was activated duringexhalation, and suction was used to remove the smoke from thesurgical field. Subjects received postoperative antibiotics,analgesics, antiinflammatories and dilute hydrogen peroxidegargles for 7 days.

Outcome Measurements

The primary outcome measurement was the reduction in AHI inthe LAUP group versus the control group. Treatment success wasdefined as a reduction in AHI to 10 or less per hour. Treatmentfailure was defined as an inadequate reduction in AHI (post-treatmentAHI of more than 10 per hour). A complete response was definedas a reduction in AHI to 10 or less per hour along with a satisfactorysymptomatic response (as determined by the patient). Subjectiveoutcomes included snoring frequency and severity, change insymptoms (e.g., excessive daytime sleepiness), and quality oflife.

The sample size was calculated with data from published studiesof LAUP (12¨C16). The study had a 90% power to detect a25% reduction in AHI in the treatment group compared with noreduction in AHI in the control group with an

THE END

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