Clinical Studies Conclude Outcomes are Equivalent for Patients Managed by Non-Sleep and Sleep Providers

There is now a large body of published science on sleep apnea patient outcomes. These studies consistently demonstrate that a home test and auto-titrating PAP results in equal or better outcomes than a referral to a sleep center for the traditional laboratory-based diagnostic test and laboratory PAP titration test.

Kunisaki et al. Provider Types an Outcomes in Obstructive Sleep Apnea Case Finding and Treatment: A Systematic Review. Annuals of Internal Medicine. Annals.Org. Jan 2018.

The Authors reviewed published studies between January 2000 and July 2017 on the topic of outcomes with Sleep Apnea patients. They concluded that care provided by non-sleep trained providers was equivalent to care provided by providers certified in Sleep Medicine when measured by patient outcomes.

Kim et al. 2015. An economic evaluation of home versus laboratory-based diagnosis of obstructive sleep apnea. Sleep 38(7), 1027–37.

Kim et al. evaluated 373 patients referred to seven sleep centers in a random assignment design and concluded (a) outcomes were equal in PAP acceptance and PAP compliance and (b) healthcare costs were lower using home test and auto-titrating PAP versus In-Lab PSG and PAP titration.

Kuna ST et al. 2011. Noninferiority of functional outcome in ambulatory management of obstructive sleep apnea. American Journal of Respiratory Critical Care Medicine 183(9), 1238–1244.

The study compared functional outcomes and adherence to treatment by randomization of patients to a hospital PSG or a home test, followed by three nights of auto-titrating PAP at home. Both groups had significantly improved functional outcomes. The authors concluded that the functional outcome and adherence to treatment in the hospital group was not superior to the home group.

Skomro RP et al. 2010. Outcomes of home-based diagnosis and treatment of obstructive sleep apnea. Chest 138(2), 257–263.

Skomro et al. compared two groups of patients. In the first group, the diagnosis was made by unsupervised home test. The patients were then titrated for a week with an auto-titrating PAP. In parallel, an In-Lab PSG was performed with blind results for the investigators. In the other arm of the analysis, the patients underwent hospital PSG with titration, before a pressure was chosen and a home test taken, again with blind results for the researchers. A wide range of four clinically accepted, commonly used outcome measurements were completed before and after the PAP treatment. The authors found no group differences in any of the outcome variables.

Rosen CL et al. 2012. A multisite randomized trial of portable sleep studies and positive airway pressure autotitration versus laboratory-based polysomnography for the diagnosis and treatment of obstructive sleep apnea: the HomePAP study. Sleep 35(6), 757–767.

This multicenter study evaluated Home-based versus Lab-based testing and treatment of OSA. At three months, the time of PAP use was one hour more in the home-based group with 12.6% greater adherence compared hospital-based regimen. On assessment of patient outcomes, they concluded Home-based is not inferior to Lab-based management.

Mulgrew AT et al. 2007. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Annuals of Internal Medicine 146(3), 157–166.

Mulgrew et al. compared matched subjects in either an At-Home diagnostic and PAP treatment process or an In-Lab PSG diagnostic and PAP treatment process. At three month follow-up they found greater adherence to treatment in the At-Home diagnostic and treatment process group versus In-Lab group.

Atwood, C. 2012. The Times They Are A Changin:” Home Diagnosis of Sleep Apnea Has Arrived. Sleep 35(6) 735–736.

In a critical review of studies comparing OSA patients managed via traditional In-Lab PSG versus an At-Home process, Atwood concluded that published clinical studies over the past five years consistently and uniformly demonstrate “essential equivalency between the At-Home diagnostic and treatment approach and the Lab-Based diagnostic and treatment approach for initial PAP adherence and initial functional outcomes.”

Peer review published studies in two prominent sleep disorder centers validated the Snap Test.

Su et al. 2004; A comparison of polysomnography and a portable home sleep study in the diagnosis of obstructive sleep apnea (OSA) syndrome. Otolaryngology – Head & Neck Surgery Vol 131 (6); 844-850.

In a study conducted at the University of Chicago Sleep Center patients underwent a Snap Test and traditional PSG on the same night. Authors concluded that the Snap Test “is an excellent tool for the diagnosis of OSA.”

Michaelson et al. 2006; Validations of a portable home sleep study with twelve-lead polysomnography (PSG): Comparisons and insights into a variable gold standard. Annals of Otogology, Rinology, and Laryngology: Vol 115 (11); 802-809.

In a study conducted by the Sleep Center at Wilford Hall US Air Force Medical Center patients underwent a Snap Test and 12-lead PSG. Authors concluded that the “convincing correlation” between the Snap Test and PSG demonstrates that the Snap Test is “a suitable alternative to traditional PSG” and a home test is less expensive, decreases patient wait times, increases convenience, and is statistically proven to be accurate.

Medicare led the way home by accepting home sleep tests.

After analyzing years of published, peer review clinical research and patient outcomes, in 2008 Medicare began accepting a home sleep test as a diagnostic standard for sleep apnea.

The Medicare decision paved the way for commercial insurance providers. The laboratory PSG is no longer the solitary gold standard in identifying patients with sleep apnea.

Studies show that on average patients suffer from sleep apnea for a decade prior to their diagnosis.

S Redline. 2017. Screening for obstructive sleep apnea: Implications for the sleep health of the population. Journal of the American Medical Association (JAMA); Vol 317(4) 368.

 

Redline’s review cited studies in which over 34% of patients reported the delay between their symptoms and OSA diagnosis exceeded 10 years and that patients on average had over 17 visits to a medical office between symptom onset and diagnosis.

Patient outcomes can reveal dramatic improvement with proper diagnosis, treatment and management.

Source: Frost & Sullivan Report (2016). What benefits do patients experience in treating their OSA.

Treatment improves quality of life.

Seventy-seven percent of patients with untreated OSA report overall life quality to be poor or very poor. Post treatment only five percent of patients report overall life to quality to be poor or very poor.

Likewise, only seven percent of patients with untreated OSA report overall life quality to be good or very good. Post treatment seventy-six percent of patients report overall life to quality to be good or very good.

Clinical Practice Guidelines for Managing OSA Patients.

L Epstein et al. 2009. Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. Journal of Clinical Sleep Medicine; Vol 5(3) 263-276.

 

“The diagnostic strategy includes a sleep-oriented history and physical examination, objective testing, and education of the patient. The presence or absence and severity of OSA must be determined before initiating treatment in or to identify those patients at risk of developing the complications of  of sleep apnea, guide the selection of appropriate treatment, and to provide a baseline to establish the effectiveness of subsequent treatment.”

“All patients with OSA should have ongoing, long-term management for their chronic disorder. Those on chronic therapy (PAP, Oral Appliance, positional therapy) should have regular, ongoing follow-up to monitor adherence to therapy, side effects, development of medical complications related to OSA and continued resolution of symptoms.” 

Ramar et al. (2015) Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. Journal of Clinical Sleep Medicine. Vol 11(7) 773-792.

 

The authors provide a clinical practice guideline that was adopted by the American Academy of Sleep Medicine (AASM) and American Academy of Dental Sleep Medicine (AADSM) for the use of Oral Appliance Therapy. They conclude that the AASM and AADMS expected the guidelines to have a positive impact on patient outcomes and potentially health care costs.

Clinical studies confirm validity of formula to estimate initial PAP pressures.

Miljeteig & Hoffstein (1993) Determinants of Continuous Positive Airway Pressure Level for Treatment of Obstructive Sleep Apnea. Am. Rev Resp Dis. Vol. 147. 1526-1530.

 

The study compared initial PAP pressures that were determined from an in-lab PAP titration study with a pressure that was derived from a mathematical fomula. The authors concluded that the mathematical formula agreed closely with lab derived setting. Findings supported that it was reasonable to use the predicted value for initial PAP settings.

The Snap Test was designed to meet virtually every insurance provider’s standard of care for home sleep testing.

Based on the above findings, a significant proportion of healthcare insurance providers now require the patient to undergo a home sleep test when evaluating a patient for sleep apnea.