Levels of recommendation (Standard, Guideline, Option) and levels of evidence (I-IV) are defined at the end of the "Major Recommendations" field
Treatment with continuous positive airway pressure (CPAP) must be based on a prior diagnosis of obstructive sleep apnea (OSA) established using an acceptable method (Standard).
This recommendation is based on previous American Academy of Sleep Medicine (AASM) practice parameters for the indications for polysomnography and related procedures (2005 update).
CPAP is indicated for the treatment of moderate to severe OSA (Standard).
This recommendation is based on 24 randomized controlled trials meeting Level I or II evidence-based medicine criteria.
CPAP is recommended for the treatment of mild OSA (Option).
This recommendation as an option is based on mixed results in 2 Level I and 3 Level II outcome studies in patients with mild OSA.
CPAP is indicated for improving self-reported sleepiness in patients with OSA (Standard).
This recommendation is based on 10 randomized controlled trials in which CPAP reduced sleepiness more than control procedures in patients with OSA.
CPAP is recommended for improving quality of life in patients with OSA (Option).
This recommendation as an option is based on inconsistent results from 2 Level I studies and 4 Level II studies with placebo control, and 1 Level II study with conservative therapy as the control.
CPAP is recommended as an adjunctive therapy to lower blood pressure in hypertensive patients with OSA (Option).
This recommendation as an option is based on 9 clinical trials, 6 of which did not find changes in mean arterial pressure compared to placebo.
Full-night, attended polysomnography performed in the laboratory is the preferred approach for titration to determine optimal positive airway pressure; however, split-night, diagnostic-titration studies are usually adequate (Guideline).
This recommendation is based on 1 Level II and 6 Level IV studies.
CPAP Usage should be objectively monitored to help assure utilization (Standard).
This recommendation is based on overwhelming evidence at all levels indicating patients with OSA overestimate their positive airway pressure. Level I and Level II studies indicate that objectively-measured nightly CPAP "time on" ranges from 3.5 hours/night in minimally symptomatic new patients to 7.1 hours/night in established users.
Close follow-up for positive airway pressure (PAP) usage and problems in patients with OSA by appropriately trained health care providers is indicated to establish effective utilization patterns and remediate problems, if needed. This is especially important during the first few weeks of PAP use (Standard).
This recommendation is based on 61 studies that examined management paradigms and collected acceptance, utilization, and adverse events; 17 of these studies qualified as Level I.
The addition of heated humidification is indicated to improve CPAP utilization (Standard).
This recommendation is based on 3 Level I studies. There was 1 Level II study that did not find increased utilization with heated humidification. Three additional studies favored heated humidification over unheated or non-humidified CPAP.
The addition of a systematic educational program is indicated to improve PAP utilization (Standard).
This recommendation is based on 4 Level I studies, 1 Level II study, and 1 Level III study.
After initial CPAP setup, long-term follow-up for CPAP-treated patients with OSA by appropriately trained health care providers is indicated yearly and as needed to troubleshoot PAP mask, machine, or usage problems (Option).
This recommendation as an option is based on task force and SPC member consensus.
CPAP and bi-level positive airway pressure (BPAP) therapy are safe; side effects and adverse events are mainly minor and reversible (Standard).
This recommendation is based on more than 23 published reports.
While the literature mainly supports CPAP therapy, BPAP is an optional therapy in some cases where high pressure is needed and the patient experiences difficulty exhaling against a fixed pressure or coexisting central hypoventilation is present (Guideline).
This recommendation is based on 2 Level I studies which yielded no evidence that BPAP improves efficacy or adherence in the management of OSA compared to CPAP.
BPAP may be useful in treating some forms of restrictive lung disease or hypoventilation syndromes associated with daytime hypercapnia (Option).
This recommendation as an option is based on 11 studies all graded at Level III or better that overall found improvement associated with BPAP therapy.
Definitions:
Levels of Recommendations
Standard: This is a generally accepted patient-care strategy, which reflects a high degree of clinical certainty. The term standard generally implies the use of Level I Evidence, which directly addresses the clinical issue, or over whelming Level II Evidence.
Guideline: This is a patient-care strategy, which reflects a moderate degree of clinical certainty. The term guideline implies the use of Level II Evidence or a consensus of Level III Evidence.
Option: This is a patient-care strategy, which reflects uncertain clinical use. The term option implies either inconclusive or conflicting evidence or conflicting expert opinion.
Classification of Evidence
Level I: Randomized well-designed trials with low alpha and beta error*
Level II: Randomized trials with high alpha and beta error*
Level III: Nonrandomized concurrently controlled studies
Level IV: Nonrandomized historically controlled studies
Level V: Case series
*Alpha error refers to the probability (generally set at 95% or greater) that a significant outcome (e.g., p<0.05) is not a result of chance occurrence. Beta error refers to the probability (generally set at 80% to 90% or greater) that a nonsignificant result (e.g., p>0.05) is the correct conclusion of the study or studies. The estimation of beta error is generally the result of a power analysis. The power analysis includes a sample size analysis to project the size of the study population necessary to ensure that significant differences will be observed if actually present.
