TABLE VI.F. 3.

Diagnostic testing: indications for in-lab polysomnography

Study	Year	LOE	Study design	Study groups	Clinical end point	Conclusion
CHF
Abraham et al.584	2006	2b	Prospective multicenter study comparing diagnostic accuracy of ClearPath System (CPS) vs. PSG. Stable CHF with EF ≤35%	Night 1 did both in the lab and Night 2 (<3 nights apart) was home CPS. N = 50	RDI as determined by 3% desaturations for respiratory events and “flow change.”	1) Same night: RDI>5 sens 92%, spec 52%, acc 73%, AUC NR RDI>15 sens 67%, spec 78%, acc 75%, AUC NR 2) Different night: RDI>5 acc 73% RDI>15 acc 77%
de Vries et al.609	2015	1b	Prospective single center cross-sectional study in patients with chronic heart failure (stable CHF by clinical judgment).	Subjects underwent the ApneaLink (2 channel – airflow + oximetry) and simultaneous PSG at home. N = 100	AHI as determined by respiratory events required 30% drop in airflow and 4% desaturations.	AHI > 5 sens 98%, spec 60%, acc NR, AUC 0.94 AHI>15 sens 92.9%, spec 91.9%, acc NR, AUC 0.94 ICC 0.85 for categories 3) 29% CSA, 19% OSA, 13% mixed 4) Best accuracy at AHI 15. 5) Cannot differentiate CSA vs. OSA
Araújo et al.607	2018	3b	Prospective single center cross-sectional study in patients with chronic heart failure (stable CHF by clinical judgment).	Subjects were studied by the ApneaLink (2 channel – airflow + oximetry) and PSG simultaneously during in the sleep laboratory. N = 35	AHI as determined by respiratory events required 50% drop in airflow and 3% desaturations.	AHI > 5 sens 81.8%, spec 61.5%, acc 74.2, AUC 0.85 AHI>15 sens 83.3%, spec 91.3%, acc 88.6, AUC 0.93 AHI correlation r = 0.79 Highest accuracy at AHI 15. Cannot differentiate CSA vs. OSA Downgraded due to small number and EF50%.
Aurora et al.608	2018	1b	Prospective single center cross sectional study in hospitalized patients with decompensated heart failure (stabilized at the time of testing).	Subjects underwent concurrent ApneaLink Plus (3 channel – airflow, oximetry and effort belt) and PSG. Recordings blindly scored for OSA and CSA. N = 57	AHI as determined by respiratory events that required a 50% drop in airflow and 3% desaturations (PSG allowed arousals).	AHI > 5 sens 95.8%, spec 80.0%, acc NR, AUC NR Central AHI>5 sens 90.9%, spec 100%, acc NR, AUC NR 3) ICC 0.89 for categories, Obs AHI r = 0.91, Central AHI r = 0.99 58.5% central AHI > 5 4) Higher accuracy for central vs. obstructive. 5) Cannot differentiate CSA vs. OSA.
Savage et al.610	2016	1b	Prospective multicenter cross-sectional study. Stable CHF patients with an EF<45%.	Subjects underwent simultaneous Sleep Minder (airflow + movement via electromagnetic signals) and PSG. Development (D) (n = 28) and validation (V) (n = 47) groups were studied. N = 75	AHI as determined by Sleep Minder (SM) required 50% reduction in airflow only. PSG required 30% drop in flow and 4% desaturations.	AHI > 5 sens NR, spec NR, acc NR, AUC NR AHI>15 sens 70%, spec 89%, acc NR, AUC 0.85. AUC 0.85 for all, 19% misclassified (> <AHI 15) by SM. 25%/34% (D/V) with OSA, 11%/9% with CSA. Best accuracy at AHI >30. Cannot differentiate CSA vs. OSA.
COPD
Chang et al.611	2019	1b	Prospective single center cross-sectional study in outpatients with stable COPD and symptoms of OSA.	Subjects did 1 night with Nox-T3 and then an in-lab PSG with simultaneous Nox-T3 within 1 week. N = 90	AHI as determined by 2 different definitions for respiratory events: 1) Nox-T3 and PSG respiratory events required 30% drop in airflow and 4% desaturation, and 2) Nox-T3 and PSG respiratory events required 30% drop in airflow and 3% desaturation or, for PSG, an arousal.	Same night 4%: AHI>5 sens 96%, spec 84%, kappa 0.82 AHI>15 sens 95%, spec 98%, kappa 0.93 Different night 4%: AHI>5 sens 95%, spec 78%, kappa 0.75 AHI>15 sens 74%, spec 98%, kappa 0.74 Same night 3% kappa AHI>5 0.58, kappa AHI>15 0.88 Different night 3% kappa AHI>5 0.48, kappa AHI>15 0.70 Nox-T3 more often found hypoxemia (15 vs. 5 with AHI < 5 and > 5 min with sats ≤88%.)
Jen et al.612	2020	3b	Prospective single center cross-sectional study in outpatients > 40 years old with stable Gold II and III COPD and OSA symptoms.	In random order, subjects underwent 1 night PSG and WatchPAT device in the lab and another night with the WatchPAT at home. N = 33	AHI as determined by WatchPAT and PSG. WatchPAT uses PAT with either a 3% with “arousal” or 4% desaturation. PSG required 50% drop in airflow without desaturation or arousals	AHI>5 sens 96%, spec 55.6% AHI>15 sens 92.3%, spec 65.0% 3)Intraindividual AHI difference 78.8% concordance (AHI>15 and difference <10)
CVA
Chernyshev et al.614	2015	2b	Prospective single center cross-sectional study of inpatients admitted for acute ischemic stroke. Studied within 72 h of the CVA.	Subjects underwent a simultaneous PSG and HSAT within 3 days of their CVA. N = 21 BMI 33.1 (OSA) vs. 23.8 (no OSA), 66.6% had an AHI > 5, 48% had OSA, 19% had CSA	AHI as determined by HSAT and PSG. Respiratory events required 30% drop and 4% desaturation.	For OSA only: AHI>5 sens 100%, spec 85.7%, acc NR, AUC 1.0 AHI>15 sens 100%, spec 83.9%, acc NR, AUC 0.95 Intraindividual AHI difference 1.5 Downgraded due to small number.
Failed HSAT
Zeidler et al.615	2015	2b	Retrospective single center review of patients referred for OSA evaluation who had a technically inadequate (N = 111) or normal HSAT (N = 127) but then had a subsequent PSG.	All had a high pretest probability of OSA. N = 238	Respiratory events scoring criteria not defined for HSAT or PSG. OSA defined by an AHI > 5.	1) Technically inadequate HSAT: 71% with OSA: 38.7% mild, 32.4% moderate/severe 2) Normal HSATs: 24% OSA: 18.1% mild, 5.5% moderate/severe Older age and lower ESS were associated with OSA on PSG.