Study design considerations for sleep-disordered breathing devices.

None: In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop focused on clinical investigations of SDB devices. Sleep medicine experts discussed appropriate definitions of terms used in the diagnosis and treatment of SDB, the use of home sleep testing versus polysomnography, clinical trial design issues in studying SDB devices, and current and future trends in digital health technologies for diagnosis and monitoring SDB. The panel's breadth of clinical expertise and experience across medical specialties provided useful and important insights regarding clinical trial designs for SDB devices.

Evolution in reimbursement for sleep studies and sleep centers.

Because of the rapid increase in the volume and costs of polysomnography and other sleep medicine diagnostic services, the Centers for Medicare & Medicaid Services (CMS) recently commissioned the Office of Inspector General (OIG) to review claims submitted for these services. The OIG found numerous cases of inappropriate payment for submitted claims and recommended significant changes in the CMS auditing process for polysomnography claims review. Additionally, a local Medicare Administrative Contractor released the most specific rules and regulations to date regarding billing and payment for sleep medicine services. These regulations specify covered diagnoses for submitted claims for both facility-based polysomnograms and unattended home sleep tests (HSTs) and list noncovered diagnoses that cannot be used to document medical necessity for such studies. The proposed rules specify minimum credentials for technologists performing polysomnograms and HSTs, mandate education prior to application of HST devices, demand a follow-up visit to discuss results after studies, and elaborate new requirements for physicians interpreting these studies. Providers of sleep medicine services must be prepared to provide documentation of diagnoses and indications when submitting claims for sleep services, and they can expect to be required to produce evidence of accreditation of the physicians and technologists providing services and the credentials of the sleep center. These changes will dramatically affect sleep medicine practitioners who order sleep studies and positive airway pressure therapies. Successful sleep medicine centers and sleep physicians alike will need to develop strategies to meet these new challenges.

Altered circadian rhythmicity in patients in the ICU.

BACKGROUND: Patients in the ICU are thought to have abnormal circadian rhythms, but quantitative data are lacking. METHODS: To investigate circadian rhythms in the ICU, we studied core body temperatures over a 48-h period in 21 patients (59 ± 11 years of age; eight men and 13 women). RESULTS: The circadian phase position for 17 of the 21 patients fell outside the published range associated with morningness/eveningness, which determines the normative range for variability among healthy normal subjects. In 10 patients, the circadian phase position fell earlier than the normative range; in seven patients, the circadian phase position fell later than the normative range. The mean ± SD of circadian displacement in either direction (advance or delay) was 4.44 ± 3.54 h. There was no significant day-to-day variation of the 24-h temperature profile within each patient. Stepwise linear regression was performed to determine if age, sex, APACHE (Acute Physiology and Chronic Health Evaluation) III score, or day in the ICU could predict the patient-specific magnitude of circadian displacement. The APACHE III score was found to be significantly predictive of circadian displacement. CONCLUSIONS: The findings indicate that circadian rhythms are present but altered in patients in the ICU, with the degree of circadian abnormality correlating with severity of illness.