Equivalence of Autoadjusted and Constant Continuous Positive Airway Pressure in Home Treatment of Sleep Apnea*

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1 Original Research SLEEP MEDICINE Equivalence of Autoadjusted and Constant Continuous Positive Airway Pressure in Home Treatment of Sleep Apnea* Yvonne Nussbaumer, MD; Konrad E. Bloch, MD, FCCP; Therese Genser; and Robert Thurnheer, MD, FCCP Whether computerized autoadjusted continuous positive airway pressure (acpap) is effective or even superior to constant continuous positive airway pressure (ccpap) in the treatment of obstructive sleep apnea syndrome (OSAS) is still controversial. We performed a randomized, double-blind, controlled, cross-over trial comparing efficacy of sleep apnea home therapy by a novel acpap machine (REMStarAuto; Respironics; Murrysville, PA) operated in autoadjusted or constant mode. Thirty sleep apnea patients were recruited consecutively. Mean baseline Epworth sleepiness scale (ESS) score was ( SD), mean sleep resistance time was 26 2 min (Osler test; Stowood Scientific Systems; Oxford, UK), and mean apnea-hypopnea index (AHI) was h. Patients were randomly assigned to 1 month of home therapy with acpap followed by 1 month with ccpap, or vice versa. After 1 month with treatment, the mean ESS score, sleep resistance time, and AHI were significantly improved ( , 37 1 min, and h, respectively; all p < 0.05 vs baseline). Similar effects were achieved with ccpap (p not significant vs acpap). Twenty-six patients preferred acpap, and 4 patients preferred ccpap (p < 0.001). We conclude that patients with OSAS preferred acpap over ccpap in the initial phase of therapy. The effectiveness acpap in improving major outcomes was equivalent to ccpap. Since acpap does not require initial titration, it is a simple and promising modality for sleep apnea home therapy. (CHEST 2006; 129: ) Key words: auto-continuous positive airway pressure; continuous positive airway pressure; randomized trial; sleep apnea; treatment; vigilance Abbreviations: acpap autoadjusted continuous positive airway pressure; AHI apnea-hypopnea index; ccpap constant continuous positive airway pressure; CI confidence interval; ESS Epworth sleepiness scale; NS not significant; ODI oxygen desaturation index; OSAS obstructive sleep apnea syndrome; SF-36 Short Form-36 The obstructive sleep apnea syndrome (OSAS) is an important disorder affecting between 2% and 4% of adults. 1 OSAS is associated with excessive daytime sleepiness, impaired quality of life, and risk of traffic accidents. 2,3 Continuous positive airway pressure (CPAP) applied to the nose, the standard treatment for OSAS, improves vigilance, quality of *From the Pulmonary Division (Drs. Nussbaumer and Thurnheer and Ms. Genser), Department of Internal Medicine, Kantonsspital Münsterlingen, Münsterlingen; and Pulmonary Division (Dr. Bloch), Department of Internal Medicine, University Hospital of Zurich, Zurich, Switzerland. The study was supported by MEDELA AG, Switzerland, distributor of Respironics products in Switzerland. Manuscript received May 31, 2005; revision accepted September 15, life, and traffic safety. 4 6 The therapeutic mask pressure that abolishes apnea, hypopnea, and snoring in all sleep stages and body positions has conventionally been determined by manual in-laboratory titration. 7 This is expensive and responsible for long waiting lists. In addition, the therapeutic CPAP determined in a single titration night is a tradeoff between pressure-related side effects and efficacy in preventing upper-airway obstruction. This is because Reproduction of this article is prohibited without written permission from the American College of Chest Physicians ( org/misc/reprints.shtml). Correspondence to: Robert Thurnheer, MD, FCCP, Pulmonary Division, Department of Internal Medicine, Kantonsspital Münsterlingen, 8596 Münsterlingen, Switzerland; robert.thurnheer@stgag.ch 638 Original Research

2 the pressure required to maintain upper-airway patency changes during a night depending on body position, sleep stage, nasal obstruction, ingestion of alcohol or hypnotic agents, 8 and over time based on changes in body weight and upper-airway properties. This variability of CPAP requirement has generated considerable interest in devices adjusting mask pressure by feedback control according to patterns of pressure, flow, or other signals during treatment (autoadjusted CPAP [acpap] devices). Autoadjustment of treatment pressure allows for a decrease in CPAP when apneas and hypopneas disappear, and an increase when respiratory disorders reappear. This has led to the assumption that continuous adaptation of mask pressure to the actual needs of the patient might improve effectiveness of therapy by preventing sleep disturbances from unnecessarily high mask pressures, by enhancing comfort and treatment adherence. 9 Mean mask pressure applied during acpap home therapy is generally lower than the manually titrated pressure. 10,11 Compliance with acpap was higher than with constant CPAP (ccpap) in some studies 9,12 but not all studies. 10,11 Whether acpap home therapy results in similar or even greater improvement of subjective and objective sleepiness and respiratory disturbances as ccpap is still a matter of debate. 10,13,14 Since acpap has the potential to enhance comfort and simplify sleep apnea therapy, we tested the hypothesis that treatment effects are equivalent when the same machine (REM-Star Auto; Respironics; Murrysville, PA) is operated in the acpap vs ccpap mode during the initial phase of home therapy. A prospective, double-blind randomized, cross-over protocol was employed. Main outcomes were the differences between the treatment modes in subjective and objective sleepiness, quality of life, nocturnal breathing disturbances, and compliance, as well as preference for one or the other mode. Some of these results have been reported in the form of an abstract. 15 Patients Materials and Methods Consecutive patients with excessive sleepiness and apneahypopnea index (AHI) 10 obstructive events per hour were included. Patients with congestive heart failure, chronic rhinitis, and other sleep disorders were excluded. The protocol was approved by the local ethics committee. For the diagnosis of sleep apnea, unattended home sleep studies were performed with a 7-channel respiratory polygraph (PolyMESAM; MAP; Martinsried, Germany), 16 recording nasal airflow, 17 thoracoabdominal movement, ECG, oxygen saturation, body position, and leg movement. The polygraph was mounted by the study nurse in the outpatient clinic. Time periods from 11 pm to 5:30 am were taken for automated analysis. All sleep studies were manually controlled scoring 1-min epochs. Apnea was defined as a cessation of airflow at the nose for at least 10s, and hypopneas were scored when a decrease in the amplitude of airflow signal to 50% of the level prevailing before the event accompanied by a fall in oxyhemoglobin saturation of at least 3% was identified. Home monitoring has been shown to be as reliable as laboratory polysomnography in the prediction of success of nasal CPAP treatment, at least in patients without significant comorbidity. 18 Blower Machine The REMStar Auto device, an acpap machine programmable by an insertable computer chip card, was employed. In six patients, the 90th pressure percentile applied by the REM-Star Auto device was not statistically different from the ninetieth percentile applied by a previously validated device (Res Med AutoSet; Respironics) 11 during 2 titration nights, one with each device. Mean 90th pressures percentiles were 7.0 (SE, 0.37) and 7.9 (SE, 0.54) cm H 2 O, respectively (p not significant [NS]). Protocol Patients were instructed that they would sleep with a blower device working in different modes without giving further information about the modes. The patients were treated over two periods of 1 month with acpap and ccpap modes, respectively, applied by the same device in random order. At the time of randomization, a pair of two identically looking chip cards was assigned to each patient. One card contained the code to operate the CPAP device in constant mode at the 90th pressure percentile applied during 1-night acpap titration. The other card contained the code to operate the CPAP device in acpap mode with a pressure range from 5 to 15 cm H 2 O. Patients were instructed to use the CPAP device for 1 month with one of the two cards, and for another month with the other card. Patients and attending physicians were blinded to treatment modes and order of application. Measurement and Outcomes Subjective sleepiness was assessed by the Epworth sleepiness scale (ESS). 19 Health-related quality of life was assessed by the Short Form-36 (SF-36) questionnaire. 20 Symptoms, treatment benefits, and side effects were rated by patients on visual analog scales ranging from 0 to 100 mm. Daytime vigilance was evaluated by the Osler test 21,22 (Stowood Scientific Systems; Oxford, UK). The mean time until seven successive responses to a light signal were missed, and the mean number of missed stimuli per minute 23 were recorded during two test sessions on the same day at 9 am and 11 am. Statistical Analysis Data are summarized as mean SE. Repeated evaluations were performed with paired t tests or analysis of variance. Preference of CPAP mode was calculated with the Fisher exact p test. The agreement between applied mask pressure during ccpap and acpap treatment was assessed by the method of Bland and Altman. 24 The effect size was calculated as ratio of the mean difference to baseline to the SD of the mean at baseline. 25 An effect size of 0.2 is considered small, 0.5 is considered intermediate, and 0.8 is considered high. According to Jones and coworkers, 26 equivalence between treatment modes was assumed if the 95% confidence interval (CI) of an observed difference fell entirely within a specified CHEST / 129 / 3/ MARCH,

3 equivalence range. Differences in the ESS score of 2 points, 5 in the SF-36 vitality score of 10 points, 4 in AHI of 5/h, and in sleep resistance time 4 min were considered to reflect equivalence. 5 With a sample size of 30 patients, the study was powered with 80% to detect the following significant differences in major outcomes ( 0.05): ESS score, 1; SF-36 vitality score, 11; AHI, 5/min; sleep resistance time, 3 min. Patients Results Thirty-four patients were included; 4 of these patients did not complete the protocol. Two patients were given humidifiers, one stopped treatment because of claustrophobia, and another subject was unavailable for follow-up. Results from 27 men and 3 women were available for analysis. The mean age was 49 years (SE, 2 years; range, 29 to 65 years), mean body mass index was 31.1 kg/m 2 (SE, 0.6 kg/m 2 ), and mean neck circumference was 42.7 cm (SE, 2.2 cm). Outcomes The effect of treatment with acpap was compared to that with ccpap and to baseline. Main results are given in Table 1. Individual results for subjective vigilance as well as for AHI are shown in Figures 1, 2. Figure 1. Individual results of ESS scores at baseline and with the two different treatment modes. Subjective Assessment There was a significant and clinically relevant improvement in symptoms by both treatment modalities to a similar degree. Mean decrease in the ESS score was 6 points for ccpap and acpap. The effect size was 1.99 for ccpap and 2.07 for acpap. The 95% CI of the mean difference between the treatment modalities was 1.6 to 1.1, suggesting equivalence (Fig 3). The SF-36 vitality score was significantly improved with either treatment, whereas in the other domains of the SF-36 no significant differences to baseline were found (Table 1). Overall acceptance was not different between CPAP modes (Table 2). At the end of the study, all patients wished to continue CPAP therapy. When asked which treatment period they had preferred (before unblinding) 26 patients opted for the period Table 1 Effects of acpap and ccpap Therapy* Variables Baseline ccpap acpap Subjective assessment ESS SF-36 physical functioning score SF-36 role physical score SF-36 bodily pain score SF-36 general health score SF-36 vitality score SF-36 social functioning score SF-36 role emotional score SF-36 mental health score Objective vigilance Osler test sleep resistance, min Nocturnal respiration AHI, /h ODI, /h Treatment pressure Mean applied mask pressure, cm H 2 O Compliance Percentage of days with 4 h of use, % Mean use per night, h *Data are presented as mean SE. p 0.05 vs baseline. p 0.05 vs ccpap. 640 Original Research

4 Figure 2. Individual results of AHI at baseline and with the two different treatment modes. with acpap, whereas only four preferred ccpap (Fisher exact test, p 0.001). The sleep questionnaire indicated significant differences in noise perception and discomfort from high pressure in favor of acpap (Table 1). No differences in sleep quality, side effects from mask and nasal discomfort or symptoms from mouth leak were noted. More relevant side effects requiring interruption of therapy or consultations were absent. Objective Daytime Vigilance Sleep resistance improved significantly, independent of CPAP mode. With ccpap, mean sleep resistance time improved by 8.1 min (SE, 1.7 min), and with acpap by 10.9 min (SE, 2.0 min) [p vs baseline; p NS between groups]. The effect sizes were 0.69 for ccpap and 0.93 for acpap. Although the difference in sleep resistance between the two CPAP modes were not statistically significant (37.2 min with acpap vs 34.4 min with ccpap), equivalence could not be confirmed, since the 95% CI of the difference ( 0.2 to 5.8 min) extended beyond the predefined range of 4 min in favor of acpap (Fig 3). Missed stimuli per minute decreased significantly from baseline by 0.36 (SE, 0.09) with acpap and by 0.67 (SE, 0.14) with ccpap (p NS). Nocturnal Respiration, Treatment Pressure, and Compliance At baseline, mean AHI was 41.1/h (SE, 3.6/h) and mean oxygen desaturation index (ODI) was 29.0 (SE, 4.0). Mean AHI decreased significantly by 35.7/h (SE, 3.2/h) with ccpap and by 36.5/h (SE, 3.7/h) with acpap (p 0.05 vs baseline; p NS between CPAP modes). Equivalence of both treatment modes was confirmed with a 95% confidence interval of the difference from 1.7 to 3.3, which falls entirely within the range of equivalence of AHI of 5/h (Fig 3). The mean ODI was reduced by 25.0/h (SE, 3.5/h) and 24.8/h (SE, 3.8/h), respectively (p 0.05 vs baseline; p NS between CPAP modes). Treatment effect size for AHI was 1.82 for ccpap and 1.86 for acpap; corresponding values for ODI were 1.13 and 1.12, respectively. Mean mask pressure during 1 month of therapy was lower with acpap. Mean difference was 1.3 cm H 2 O (SE, 0.4 cm H 2 O; 95% CI, 2.1 to 0.5 cm H 2 O; p 0.05). Mean nightly CPAP use of 4.8 h (SE, 0.3 h) with ccpap was similar to that with acpap of 5.1 h (SE, 0.3 h) [p NS; Table 1]. In each group, there was one patient with nonadherence (use 2 h), and there were eight patients in the ccpap group and eight patients in the acpap group with mean nightly use 6h. Discussion Figure 3. To evaluate whether the effects of acpap and ccpap were equivalent, the 95% CIs of the differences in major outcomes are displayed as solid horizontal lines. Differences are computed as values during autoadjusted minus corresponding values during ccpap therapy. Vertical dashed lines delineate equivalence ranges assumed to represent no clinically relevant difference. While none of the differences were statistically significant, the 95% CIs of differences in SF-36 vitality scores, and sleep resistance time extended beyond the equivalence ranges in favor of acpap. The meaning of a positive difference is indicated at the right side of each panel. In this double-blind, randomized, controlled trial, 1 month of acpap treatment was equivalent to ccpap in improving major outcomes of sleep apnea therapy, including daytime sleepiness, impaired quality of life, and nocturnal respiratory disturbances. With both treatment modes, a significant and clinically relevant relief of the symptoms of OSAS was achieved. Our results suggest that the algorithm implemented in the acpap device per- CHEST / 129 / 3/ MARCH,

5 Table 2 CPAP Tolerance and Preference* Variables Constant CPAP Autoadjusted CPAP CPAP tolerance and sleep questionnaire Problem with mask leaks? Problem with mouth leaks? General fit of mask? How much refreshed do you feel this morning? Do you suffer from nasal stuffiness? Do you suffer from sore or dry mouth/throat? How uncomfortable was the air pressure? How difficult was it falling asleep? Noise of CPAP-device? Did you have difficulties in maintaining sleep? How restoring was your sleep? How well did you sleep? Overall benefit during treatment Overall, how easily did you tolerate this treatment? Preference Patients preferring CPAP mode, No *Data are presented as mean SE unless otherwise indicated. Questionnaire data are on a visual analogue scale (range, 0 to 100 mm); lower values better; questions relate to the entire 4-week periods with the two treatment modes. p 0.05 vs ccpap. p vs ccpap. forms well in respiratory event detection and automatic mask pressure adjustment, and that this is appreciated by the patients who indicated a clear preference for the acpap compared to the ccpap mode. The effect sizes achieved in major outcomes with acpap and ccpap therapy of 1.82 for AHI, 1.99 for ESS score, and 0.69 for sleep resistance time compare favorably with previous evaluations of ccpap (effect sizes 1.61, 1.40, and 0.38, respectively). 27 Effect sizes 0.8 are considered as clinically important. 25 Moreover, acpap was at least equivalent to ccpap in improvement of these outcomes (Fig 3). Mean CPAP use of 5.1 h for acpap and 4.8 h for ccpap is comparable to previous studies 5,10 and clearly exceeds a mean use of 3.4 h considered as the lower end of treatment time that provides a clinically significant treatment benefit. 28 The 90th pressure percentile titrated during a night of acpap adaptation has been taken for ccpap treatment in accordance to a previous study 29 with the ResMed AutoSet device, in which the 90th percentile best approximated manually titrated CPAP pressure. In the comparison we performed in six patients, the 90th pressure percentiles titrated with the ResMed AutoSet and the REMstar Auto showed no significant difference, and the treatment effects on respiratory disturbance and vigilance were similar to those in previous studies. 27,28 In one study, 30 autoadjusted titration has been shown to represent a valid alternative to standard in-laboratory CPAP titration. Previous studies have addressed the efficacy of acpap devices in home therapy of OSAS over several weeks. A randomized study 14 including eight patients treated for 3 weeks with the Morphée autocpap device (Pierre Medical; Verrieres le Buisson, France) in automatic mode and eight patients in constant mode revealed a better compliance in the acpap group of 6.5 h per night vs 5.1 h per night in the ccpap group. In 1997, Sériès and Mark 13 demonstrated in a small (n 10) cross-over study a similar AHI when patients were treated with the Morphée acpap device compared to manually titrated ccpap. In a single-blind parallel study, Konermann et al 9 found better compliance, sleep quality, and lower treatment pressures with acpap with the Horizon machine (De Vilbiss; Somerset, PA) compared to ccpap. However, no data on daytime vigilance were available for this cohort. 9 A similar parallel study 31 using the Somnosmart device (Weinmann; Hamburg, Germany) also reported lower treatment pressures and higher preference for acpap, but no objective data about daytime vigilance were available either. In a randomized crossover study, patients selected according to their requirements for a high therapeutic pressure 10 cm of H 2 O were treated with AutoSet T or with manually titrated fixed pressure over 6 weeks each. The AutoSet T (ResMed; North Ryde, Australia) mode was superior in sleep symptom scores, SF-36 vitality, and mental health scores. Moreover, median treatment pressures were lower and adherence per night was significantly better with the autoadjusting device, but objective vigilance was not assessed. In a randomized trial 10 of two acpap devices vs ccpap 642 Original Research

6 addressing objective and subjective sleepiness, nocturnal breathing disturbances, treatment adherence, and quality of life, no differences between ccpap and acpap by the two tested devices (AutoAdjust LT; DeVilbiss; AutoSet T; ResMed) were found. Conclusions This double-blind, randomized, controlled trial compares ccpap to acpap in the home treatment of obstructive sleep apnea. Our investigation adds to the evidence demonstrating equivalent improvements of symptoms and measured sleep resistance by acpap using a novel device. We found no advantage of acpap regarding major outcome parameters such as objective sleepiness, symptoms, or quality of life, but the majority of patients preferred treatment in the autoadjusting mode. Therefore, acpap is a promising alternative to conventional CPAP treatment with fixed mask pressure. References 1 Young T, Palta M, Dempsey J, et al. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med 1993; 328: Baldwin CM, Griffith KA, Nieto FJ, et al. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep 2001; 24: Findley LJ, Weiss JW, Jabour ER. Drivers with untreated sleep apnea: a cause of death and serious injury. Arch Intern Med 1991; 151: Montserrat JM, Ferrer M, Hernandez L, 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: Jenkinson C, Davies RJ, Mullins R, et al. Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial. Lancet 1999; 353: George CF. Reduction in motor vehicle collisions following treatment of sleep apnoea with nasal CPAP. Thorax 2001; 56: Montserrat JM, Ballester E, Olivi H, et al. Time-course of stepwise CPAP titration: behavior of respiratory and neurological variables. Am J Respir Crit Care Med 1995; 152: Teschler H, Berthon-Jones M, Wessendorf T, et al. Influence of moderate alcohol consumption on obstructive sleep apnoea with and without AutoSet nasal CPAP therapy. Eur Respir J 1996; 9: Konermann M, Sanner BM, Vyleta M, et al. Use of conventional and self-adjusting nasal continuous positive airway pressure for treatment of severe obstructive sleep apnea syndrome: a comparative study. Chest 1998; 113: Senn O, Brack T, Matthews F, et al. Randomized short-term trial of two autocpap devices versus fixed continuous positive airway pressure for the treatment of sleep apnea. Am J Respir Crit Care Med 2003; 168: Teschler H, Wessendorf TE, Farhat AA, et al. Two months auto-adjusting versus conventional ncpap for obstructive sleep apnoea syndrome. Eur Respir J 2000; 15: Massie CA, McArdle N, Hart RW, et al. Comparison between automatic and fixed positive airway pressure therapy in the home. Am J Respir Crit Care Med 2003; 167: Sériès F, Marc I. Efficacy of automatic continuous positive airway pressure therapy that uses an estimated required pressure in the treatment of the obstructive sleep apnea syndrome. Ann Intern Med 1997; 127: Meurice JC, Marc I, Sériès F. Efficacy of auto-cpap in the treatment of obstructive sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 1996; 153: Thurnheer R, Genser Th, Ochsner Y. Constant vs. automated CPAP: a prospective double-blind randomized controlled crossover trial [abstract]. Am J Respir Crit Care Med 2004; 15:A Marrone O, Salvaggio A, Insalaco G, et al. Evaluation of the POLYMESAM system in the diagnosis of obstructive sleep apnea syndrome. Monaldi Arch Chest Dis 2001; 56: Thurnheer R, Xie X, Bloch KE. Accuracy of nasal cannula pressure recordings for assessment of ventilation during sleep. Am J Respir Crit Care Med 2001; 164: Whitelaw WA, Brant RF, Flemons WW. Clinical usefulness of home oximetry compared with polysomnography for assessment of sleep apnea. Am J Respir Crit Care Med 2005; 171: Bloch KE, Schoch OD, Zhang JN et al. German version of the Epworth Sleepiness Scale. Respiration 1999; 66: Ware JE, Snow KK, Kosinski M, et al. SF-36 health survey: manual and interpretation guide. Boston, MA. The Health Institute, New England Medical Center Bennett LS, Stradling JR, Davies RJ. A behavioural test to assess daytime sleepiness in obstructive sleep apnoea. J Sleep Res 1997; 6: Mazza S, Pepin JL, Deschaux C, et al. Analysis of error profiles occurring during the OSLER test: a sensitive mean of detecting fluctuations in vigilance in patients with obstructive sleep apnea syndrome. Am J Respir Crit Care Med 2002; 166: Priest B, Brichard C, Aubert G, et al. Microsleep during a simplified maintenance of wakefulness test: a validation study of the Osler test. Am J Respir Crit Care Med 2001; 163: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 11: Kazis LE, Andersen JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care 1989; 27:S178 S Jones B, Jarvis B, Ebutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996; 313: Kingshott RN, Vennelle M, Hoy CJ, et al. Predictors of improvements in daytime function outcomes with CPAP therapy. Am J Respir Crit Care Med 2000; 161: Engleman HM, Martin SE, Deary IJ, et al. Effect of CPAP therapy on daytime function in patients with mild sleep apnoea/ hypopnoea syndrome. Thorax 1997; 52: Lloberes P, Ballester E, Montserrat JM, et al. Comparison of manual and automatic CPAP titration in patients with sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 1996; 154: Masa JF, Jimenez A, Duran J, et al. Alternative methods of titrating continuous positive airway pressure: a large multicenter study. Am J Respir Crit Care Med 2004; 170: Randerath WJ, Schraeder O, Galetke W, et al. Autoadjusting CPAP therapy based on impedance efficacy, compliance and acceptance. Am J Respir Crit Care Med 2001; 163: CHEST / 129 / 3/ MARCH,

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