Study design considerations for sleep-disordered breathing devices.

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.

Bacterial meningitis among children with cochlear implants beyond 24 months after implantation.

Background: More than 11000 children in the United States with severe-to-profound hearing loss have cochlear implants. A 2002 investigation involving pediatric cochlear implant recipients identified meningitis episodes from January 1, 1997, through September 15, 2002. The incidence of pneumococcal meningitis in the cohort was 138.

Self-triggered functional electrical stimulation during swallowing.

Hyolaryngeal elevation is essential for airway protection during swallowing and is mainly a reflexive response to oropharyngeal sensory stimulation. Targeted intramuscular electrical stimulation can elevate the resting larynx and, if applied during swallowing, may improve airway protection in dysphagic patients with inadequate hyolaryngeal motion. To be beneficial, patients must synchronize functional electrical stimulation (FES) with their reflexive swallowing and not adapt to FES by reducing the amplitude or duration of their own muscle activity.

Suppression of thyroarytenoid muscle responses during repeated air pressure stimulation of the laryngeal mucosa in awake humans.

Repeated stimulation of the laryngeal mucosa occurs during speech. Single stimuli, however, can elicit the laryngeal adductor response (LAR). Our hypothesis was that the LAR to repeated rapid air pressure stimuli is centrally suppressed in humans.

Distal spinal and bulbar muscular atrophy caused by dynactin mutation.

Impaired axonal transport has been postulated to play a role in the pathophysiology of multiple neurodegenerative disorders. In this report, we describe the results of clinical and neuropathological studies in a family with an inherited form of motor neuron disease caused by mutation in the p150Glued subunit of dynactin, a microtubule motor protein essential for retrograde axonal transport. Affected family members had a distinct clinical phenotype characterized by early bilateral vocal fold paralysis affecting the adductor and abductor laryngeal muscles.

Practice parameter: laryngeal electromyography (an evidence-based review).

This paper reports on an evidence-based review of laryngeal electromyography (EMG) as a technique for use in the diagnosis, prognosis, and treatment of laryngeal movement disorders including the laryngeal dystonias, vocal fold paralysis, and other neurolaryngological disorders. The authors performed a systematic review of the medical literature from 1944 through 2001 on the clinical application of EMG to laryngeal disorders. The review yielded 584 articles of which 33 met the predefined inclusion criteria.

Practice parameter: laryngeal electromyography (an evidence-based review).

This paper reports on an evidence-based review of laryngeal electromyography (EMG) as a technique for use in the diagnosis, prognosis, and treatment of laryngeal movement disorders, including the laryngeal dystonias, vocal fold paralysis, and other neurolaryngological disorders. The authors performed a systematic review of the medical literature from 1944 through 2001 on the clinical application of EMG to laryngeal disorders. Thirty-three of the 584 articles met the predefined inclusion criteria.

Laryngeal electromyography: an evidence-based review.

This article reports on an evidence-based review of laryngeal electromyography (EMG) as a technique for use in the diagnosis, prognosis, and treatment of laryngeal movement disorders including the laryngeal dystonias, vocal fold paralysis, and other neurolaryngological disorders. The authors performed a systematic review of the medical literature from 1944 through 2001 on the clinical application of EMG to laryngeal disorders. Thirty-three of the 584 articles met the predefined inclusion criteria.

Risk of bacterial meningitis in children with cochlear implants.

Background: In June 2002, the Food and Drug Administration received reports of bacterial meningitis in patients with cochlear implants for treatment of hearing loss. Implants that included a positioner (a wedge inserted next to the implanted electrode to facilitate transmission of the electrical signal by pushing the electrode against the medial wall of the cochlea) were voluntarily recalled in the United States in July 2002.

Methods: We identified patients with meningitis and conducted a cohort study and a nested case-control investigation involving 4264 children who had received cochlear implants in the United States between January 1, 1997, and August 6, 2002, and who were less than six years of age when they received the implants.

Laryngeal elevation achieved by neuromuscular stimulation at rest.

During swallowing, airway protection is achieved in part by laryngeal elevation. Although multiple muscles are normally active during laryngeal elevation, neuromuscular stimulation of select muscles was evaluated to determine which single muscle or muscle pair best elevates the larynx and should be considered during future studies of neuromuscular stimulation in dysphagic patients. Hooked-wire monopolar electrodes were inserted into mylohyoid, thyrohyoid, and geniohyoid muscle regions in 15 healthy men selected for having a highly visible thyroid prominence for videotaping.

Mucosal afferents mediate laryngeal adductor responses in the cat.

Laryngeal adductor responses (LAR) close the airway in response to stimulation of peripheral afferents in the superior laryngeal nerve. Although both mucosal afferents and proprioceptive receptors are present in the larynx, their relative contribution for reflex elicitation is unknown. Our purpose was to determine which receptor types are of importance in eliciting the LAR.

The effect of neuromuscular stimulation of the genioglossus on the hypopharyngeal airway.

Objectives: To determine the effects of neuromuscular stimulation (NS) of the genioglossus muscle on hypopharyngeal airway size.

Study Design: Fourteen consecutively recruited healthy volunteers underwent percutaneous electrical NS of the genioglossus muscle.

Methods: Bipolar hooked wires were inserted percutaneously into the genioglossus muscle and used for NS.