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Physician Decision Making and Clinical Outcomes With Laboratory Polysomnography or Limited-Channel Sleep Studies for Obstructive Sleep Apnea: A Randomized Trial.

Physician Decision Making and Clinical Outcomes With Laboratory Polysomnography or Limited-Channel Sleep Studies for Obstructive Sleep Apnea: A Randomized Trial.
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Chai-Coetzer CL, Antic NA, Hamilton GS, McArdle N, Wong K, Yee BJ, Yeo A, Ratnavadivel R, Naughton MT, Roebuck T, Woodman R, McEvoy RD,


Chai-Coetzer CL, Antic NA, Hamilton GS, McArdle N, Wong K, Yee BJ, Yeo A, Ratnavadivel R, Naughton MT, Roebuck T, Woodman R, McEvoy RD, (click to view)

Chai-Coetzer CL, Antic NA, Hamilton GS, McArdle N, Wong K, Yee BJ, Yeo A, Ratnavadivel R, Naughton MT, Roebuck T, Woodman R, McEvoy RD,

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Annals of internal medicine 2017 01 10166(5) 332-340 doi 10.7326/M16-1301
Abstract
Background
The clinical utility of limited-channel sleep studies (which are increasingly conducted at home) versus laboratory polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA) is unclear.

Objective
To compare patient outcomes after PSG versus limited-channel studies.

Design
Multicenter, randomized, noninferiority study. (Australian New Zealand Clinical Trials Registry: ACTRN12611000926932).

Setting
7 academic sleep centers.

Participants
Patients (n = 406) aged 25 to 80 years with suspected OSA.

Intervention
Sleep study information disclosed to sleep physicians comprised level 1 (L1) PSG data (n = 135); level 3 (L3), which included airflow, thoracoabdominal bands, body position, electrocardiography, and oxygen saturation (n = 136); or level 4 (L4), which included oxygen saturation and heart rate (n = 135).

Measurements
The primary outcome was change in Functional Outcomes of Sleep Questionnaire (FOSQ) score at 4 months. Secondary outcomes included the Epworth Sleepiness Scale (ESS), the Sleep Apnea Symptoms Questionnaire (SASQ), continuous positive airway pressure (CPAP) compliance, and physician decision making.

Results
Change in FOSQ score was not inferior for L3 (mean difference [MD], 0.01 [95% CI, -0.47 to 0.49; P = 0.96]) or L4 (MD, -0.46 [CI, -0.94 to 0.02; P = 0.058]) versus L1 (noninferiority margin [NIM], -1.0). Compared with L1, change in ESS score was not inferior for L3 (MD, 0.08 [CI, -0.98 to 1.13; P = 0.89]) but was inconclusive for L4 (MD, 1.30 [CI, 0.26 to 2.35; P = 0.015]) (NIM, 2.0). For L4 versus L1, there was less improvement in SASQ score (-17.8 vs. -24.7; P = 0.018), less CPAP use (4.5 vs. 5.3 hours per night; P = 0.04), and lower physician diagnostic confidence (P = 0.003).

Limitation
Limited-channel studies were simulated by extracting laboratory PSG data and were not done in the home.

Conclusion
The results support manually scored L3 testing in routine practice. Poorer outcomes with L4 testing may relate, in part, to reduced physician confidence.

Primary Funding Source
National Health and Medical Research Council and Repat Foundation.

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