Effect of a prescription digital therapeutic for chronic insomnia on post-treatment insomnia severity, depression, and anxiety symptoms: results from the real-world DREAM study.

Introduction: Chronic insomnia is a substantial public health burden that often presents with co-occurring depression and anxiety. Randomized clinical trials and preliminary real-world evidence have shown that digitally delivered cognitive-behavioral therapy for insomnia (dCBT-I) is associated with improvements in insomnia, but real-world evidence is needed to determine the true impact of digital CBT-I. This pragmatic study aimed to evaluate the benefits of treating chronic insomnia with a tailored prescription digital therapeutic in a real-world population.

Efficacy and safety of TOMAC for treatment of medication-naïve and medication-refractory restless legs syndrome: A randomized clinical trial and meta-analysis.

Objective/background: There is a significant unmet need for safe and effective nonpharmacological therapies for restless legs syndrome (RLS). The objective was to evaluate the efficacy and safety of tonic motor activation (TOMAC) in patients with RLS.

Patients/methods: A multicenter, randomized, participant-blinded, sham-controlled trial enrolled 45 adults with primary moderate-to-severe RLS who were either medication-naïve (n = 20) or medication-refractory (n = 25).

Obstructive Sleep Apnea Treatment and the Evaluation of Clinical Effectiveness of Uniquely Designed Oral Appliance Therapy Device.

Background:  Continuous positive airway pressure (CPAP) has been considered first-line therapy for patients with obstructive sleep apnea (OSA); however, adherence to the therapy is suboptimal. Oral appliance therapy (OAT) is an alternative to CPAP that may lend to better patient adherence, quality of life, and overall patients' effectiveness of therapy.

Methods: This was a prospective, single-site, non-randomized study to evaluate the clinical effectiveness of a uniquely designed OAT device with an embedded adherence tracking chip in the treatment of mild and moderate OSA patients over three months.

The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial.

Obstructive sleep apnea (OSA) is a common sleep disorder for which the principal treatment option, continuous positive airway pressure, is often poorly tolerated. There is currently no approved pharmacotherapy for OSA. However, recent studies have demonstrated improvement in OSA with combined antimuscarinic and noradrenergic drugs.

Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study.

Study Objectives: To evaluate long-term efficacy and safety of tonic motor activation (TOMAC) for treatment of medication-refractory moderate-to-severe primary restless legs syndrome (RLS).

Methods: In the parent study (RESTFUL), adults with refractory RLS were randomized to active TOMAC or sham for 4 weeks followed by 4 weeks of open-label active TOMAC. In the extension study, earlier RESTFUL completers comprised the control group (n = 59), which was followed for 24 weeks with no TOMAC intervention, and later RESTFUL completers compromised the treatment group (n = 44), which received 24 additional weeks of open-label active TOMAC followed by no intervention for 8 weeks.

Evaluation of a novel device to assess obstructive sleep apnea and body position.

Study Objectives: Obstructive sleep apnea is a prevalent disease with well-known complications when left untreated. Advances in sleep-disordered breathing diagnosis may increase detection and appropriate treatment. The Wesper device is a recently developed portable system with specialized wearable patches that can measure respiratory effort, derived airflow, estimated air pressure, and body position.

The combination of atomoxetine and dronabinol for the treatment of obstructive sleep apnea: a dose-escalating, open-label trial.

Study Objectives: The potential sedative effect of dronabinol and the high expression of cannabinoid receptors on the hypoglossal motor nuclei makes this agent a good candidate for obstructive sleep apnea (OSA) pharmacotherapy to be tested with atomoxetine, a noradrenergic reuptake inhibitor that reduced OSA severity in combination with oxybutynin. Here we tested the effect of atomoxetine 80 mg plus dronabinol (Ato-Dro) at 2 different doses (5 and 10 mg) vs. baseline and atomoxetine alone in a 2-center, open-label, dose-escalating trial.

Commercial Motor Vehicle Driver Positive Airway Pressure Therapy Adherence in a Sleep Center.

Study Objectives: To assess positive airway pressure (PAP) therapy adherence in commercial motor vehicle (CMV) drivers presenting to a sleep center.

Methods: A retrospective chart review of 120 drivers evaluated for obstructive sleep apnea OSA and 53 initiated on PAP therapy in a single sleep center over a one-year period (2012); PAP therapy data were collected up to 1 year.

Results: Early PAP usage best predicted adherence up to 1 year (p < 0.

A pilot study assessing adherence to auto-bilevel following a poor initial encounter with CPAP.

Study Objectives: We hypothesized that early intervention with an auto bilevel device would improve treatment adherence compared to CPAP among OSA patients with a poor initial experience with lab-based CPAP titration.

Methods: Patients with a poor initial CPAP experience were recruited for this parallel group, randomized, double-blind, controlled pilot study. After an in-lab titration, patients were randomized with either an auto-bilevel device or CPAP.

Pulse oximetry saturation patterns detect repetitive reductions in airflow.

Objective: Postoperative patients exhibiting signs or symptoms of obstructive sleep apnea (OSA) have been identified to be at increased risk for respiratory compromise. One of the key markers associated with OSA is repetitive reductions in airflow (RRiA). A real-time pulse oximeter saturation pattern recognition algorithm (OxiMax SPD™ intended for adult in-hospital use only) designed to detect specific signatures in the SpO(2) trend associated with RRiA may provide caregivers early indication of its presence so they can treat the patient appropriately.

Obstructive sleep apnea devices for out-of-center (OOC) testing: technology evaluation.

Guidance is needed to help clinicians decide which out-of-center (OOC) testing devices are appropriate for diagnosing obstructive sleep apnea (OSA). A new classification system that details the type of signals measured by these devices is presented. This proposed system categorizes OOC devices based on measurements of Sleep, Cardiovascular, Oximetry, Position, Effort, and Respiratory (SCOPER) parameters.