A Randomized Trial of Temperature-Controlled Radiofrequency,Continuous Positive Airway Pressure,and Placebo for Obstructive Sleep Apnea Syndrome

Abstract

OBJECTIVE: The study goal was to determine the effectiveness of (1) multilevel temperature-controlled radiofrequency tissue ablation (TCRFTA) or (2) continuous positive airway pressure (CPAP) for the treatment of mild to moderate obstructive sleep apnea syndrome (OSAS).

STUDY DESIGN AND METHODS: We conducted a randomized, placebo-controlled, 2-site trial, comparing TCRFTA (n=30) and CPAP (n=30) with sham-placebo (n=30) using intention-to-treat analysis.

RESULTS: Compared with pretreatment baseline, TCRFTA improved reaction time, OSAS-specific quality of life (QOL), and subjective sleepiness (all P < 0.05). Compared with sham-placebo, TCRFTA improved QOL, airway volume, apnea index, and respiratory arousal index (all P < 0.05). TCRFTA side effects and complications were mild, temporary, and similar to sham-placebo. CPAP improved QOL and sleepiness compared with baseline and QOL when compared with sham-placebo (all P < 0.05). Significant differences were not seen between TCRFTA and CPAP outcomes.

CONCLUSION: TCRFTA and CPAP each improve QOL for mild-moderate OSAS patients. TCRFTA improvements may result from changes in airway volume, apnea index, and respiratory arousal index.

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References

Young

Palta

Dempsey

, et al. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med 1993;328:1230–5.

Sleep-related breathing disorders in adults: Recommendations for syndrome definition and measurement techniques in clinical research. The report of an American Academy of Sleep Medicine task force. Sleep 1999; 22: 667–89.

Peppard

Young

Palta

, et al. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med 2000;342:1378–84.

Peker

Hedner

Norum

, et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnea: A 7-year follow-up. Am J Respir Crit Care Med 2002;166:159–65.

Flemons

Tsai

Quality of life consequences of sleep-disordered breathing. J Allergy Clin Immunol 1997;99:S750–6.

Young

Blustein

Finn

, et al. Sleep-disordered breathing and motor vehicle accidents in a population-based sample of employed adults. Sleep 1997;20:608–13.

Engleman

Martin

Kingshott

, et al. Randomised placebo controlled trial of daytime function after continuous positive airway pressure (CPAP) therapy for the sleep apnoea/hypopnoea syndrome. Thorax 1998;53:341–5.

Montserrat

Ferrer

Hernandez

, et al. Effectiveness of CPAP treatment in daytime function in sleep apnea syndrome. A randomized controlled study with an optimized placebo. Am J Respir Crit Care Med 2001; 164: 608–13.

Engleman

Kingshott

Wraith

, et al. Randomized placebo-controlled crossover trial of continuous positive airway pressure for mild sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 1999;159:461–7.

10.

Monasterio

Vidal

Duran

, et al. Effectiveness of continuous positive airway pressure in mild sleep apneahypopnea syndrome. Am J Respir Crit Care Med 2001;164:939–43.

11.

Barnes

Houston

Worsnop

, et al. A randomized controlled trial of continuous positive airway pressure in mild obstructive sleep apnea. Am J Respir Crit Care Med 2002;165:773–80.

12.

Powell

Riley

Guilleminault

Radiofrequency tongue base reduction in sleep-disordered breathing: a pilot study. Otolaryngol Head Neck Surg 1999;120:656–64.

13.

Powell

Riley

, et al. Temperature-controlled radiofrequency tongue base reduction for sleep-disordered breathing: long-term outcomes. Otolaryngol Head Neck Surg 2002;127:230–4.

14.

Woodson

Nelson

Mickelson

, et al. A multi-institutional study of radiofrequency volumetric tissue reduction for OSAS. Otolaryngol Head Neck Surg 2001; 125: 303–11.

15.

Moher

Schulz

Altaian

The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987–91.

16.

Teschler

Berthon-Jones

Thompson

, et al. Automated continuous positive airway pressure titration for obstructive sleep apnea syndrome. Am J Respir Crit Care Med 1996;154:734–40.

17.

Jewett

Dijk

Kronauer

, et al. Dose-response relationship between sleep duration and human psychomotor vigilance and subjective alertness. Sleep 1999;22:171–9.

18.

Weaver

Laizner

Evans

, et al. An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep 1997;20:835–43.

19.

Piccirillo

Gates

White

, et al. Obstructive sleep apnea treatment outcomes pilot study. Otolaryngol Head Neck Surg 1998;118:833–44.

20.

Kazis

Anderson

Meenan

Effect sizes for interpreting changes in health status. Med Care 1989;27:S178–89.

21.

Kribbs

Pack

Kline

, et al. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis 1993;147:887–95.

22.

Weaver

Sleep apnea devices and sleep apnea surgery should be compared on effectiveness, not efficacy (letter). Chest 2003;123:961–2.

23.

Blumen

Dahan

Wagner

, et al. Radiofrequency versus LAUP for the treatment of snoring. Otolaryngol Head Neck Surg 2002;126:67–73.

24.

Powell

Riley

Troell

, et al. Radiofrequency volumetric tissue reduction of the palate in subjects with sleep-disordered breathing. Chest 1998;113:1163–74.

25.

Pazos

Mair

Complications of radiofrequency ablation in the treatment of sleep-disordered breathing. Otolaryngol Head Neck Surg 2001; 125: 462–6; discussion 6–7.

26.

McArdle

Devereux

Heidarnejad

, et al. Long-term use of CPAP therapy for sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 1999;159:1108–14.

27.

Sackett

Straus

Richardson

, et al. Evidence-based medicine: How to practice and teach EBM. Edinburgh: Churchill Livingstone; 2000. p. 261.