In suspected OSA, home respiratory polygraphy was noninferior to polysomnography for reducing symptoms

Question In patients with an intermediate to high probability for obstructive sleep apnea (OSA), is management using home respiratory polygraphy (HRP) vs in-laboratory polysomnography (PSG) noninferior for reducing symptoms? Methods Design Randomized controlled noninferiority trial. ClinicalTrials.gov NCT01752556. Allocation {Concealed}*. Blinding Blinded (physicians providing usual patient care). Follow-up period 6 months. Setting 12 tertiary hospitals in Spain. Patients 430 patients 18 to 70 years of age (median age 50 y, 71% men, median Epworth Sleepiness Scale [ESS] score 13) who were referred for consultation for suspected OSA and had ESS score 10, partner-observed snoring or sleep apnea, and no suspected alternative sleep pathology that could cause daytime sleepiness. Exclusion criteria included uncontrolled structural or coronary cardiopathy, Cheyne-Stokes syndrome, very severe nasal obstruction, or previous uvulopalatopharyngoplasty. Intervention Management using HRP (n =218) or conventional PSG (n =212). Outcomes Primary outcome was ESS. Other outcomes included Functional Outcomes of Sleep Questionnaire (FOSQ), quality of life (EuroQol-5D questionnaire), blood pressure, and PSG measures. 240 patients per group were needed to determine noninferiority of HRP compared with PSG for ESS score (noninferiority margin 2 points, 90% power, {2-sided}* =0.025, 20% dropout rate). Patient follow-up 89% completed the trial; 100% were included in the intention-to-treat analysis. Main results 53% of patients in the HRP group and 67% in the PSG group were treated with continuous positive airway pressure during the trial. Management with HRP vs PSG was noninferior for ESS score at 6 months; groups did not differ for FOSQ or EuroQol-5D scores, or 24-hour blood pressure (Table). At 6-month PSG, 20% in the HRP group vs 21% in the PSG group had deep sleep (adjusted P =0.023); groups did not differ (unadjusted P >0.10) for other PSG measures (recorded time, total sleep time [TST], patients with light sleep or REM sleep, arousal index, apneahypopnea index, desaturation index, oxygen saturation, or TST with <90% oxygen saturation). Conclusion In suspected obstructive sleep apnea, management with home respiratory polygraphy was noninferior to conventional polysomnography for reducing sleepiness symptoms. Home respiratory polygraphy (HRP) vs conventional polysomnography (PSG) in patients with suspected obstructive sleep apnea Outcomes Mean change from baseline to 6 mo Adjusted mean difference (95% CI) HRP PSG ESS score 4.2 4.8 0.63 (1.44 to 0.18) Unadjusted P value FOSQ score 6.7 6.5 0.919 EuroQol-5D score 0.01 0.03 0.311 24-h blood pressure, mm Hg 0.2 0.0 0.241 ESS = Epworth Sleepiness Scale; FOSQ = Functional Outcomes of Sleep Questionnaire; CI defined in Glossary. Provided by author Noninferiority criterion: lower limit of the 95% CI 2.0 points. Commentary The prevalence of OSA, defined as an apneahypopnea index 5 events/h, is about 10% to 40% worldwide (1). The American Academy of Sleep Medicine guidelines recommend PSG as the standard test for diagnosing OSA in adults (2); however, high prevalence of this condition imposes cost-related challenges for diagnostic testing using PSG. The randomized, noninferiority, unblinded, controlled trial conducted in Spain by Corral and colleagues suggests that an HRP-based decision-making protocol is not inferior to a PSG protocol based on ESS at 6 months, with a lower cost. The 2 groups were similar for quality of life, blood pressure, and polysomnographic outcomes at 6 months. The prespecified noninferiority margin of 2 points on the ESS is consistent with natural variations of ESS to define a minimally important difference. The external validity of the findings in this single-country trial could be affected by differences in health care systems, and it may be reasonable to include different regions of the world in future trials. Corral and colleagues used type III portable monitors for HRP. Limitations of this type of monitor include dislodgement of sensors during the study and moderate frequency of technically inadequate studies (3). Compared with conventional PSG, HRP-based testing and treatment protocols have great potential for simplifying testing and saving costs without compromising patient outcomes in OSA. Implications and limitations of HRP should be considered before widespread adoption.