A United States Market Entry Analysis for a New Medical Device

This report provides an analysis of the market opportunities for a medical device developed by io, a New Zealand based company. The device simulates a high altitude, low oxygen environment to encourage the body to develop more red blood cells. Potential medical benefits derived from anecdotal sources have encouraged the company to begin clinical trials to determine efficacy as a medical device. Before committing to a beachhead market, io is interested in understanding the business opportunities in seven different treatment areas. A balanced scorecard was used to weight the different opportunities, aligning them with io’s requirements. The results of the market analysis show that chemotherapy induced anemia would be a promising first market followed by the second tier opportunities of insomnia, asthma, obesity and sleep apnea. The lowest scoring treatment areas analyzed were headache and hypertension. This analysis is contingent on io’s efficacy data being equal for all treatment areas

No changes in nocturnal respiration with hypoglossal neurostimulation therapy for obstructive sleep apnoea

Study objectives We initiated Hypoglossal Neurostimulation therapy (HGNS) at the Helsinki University Hospital in late 2014. Here, we report our experience. Methods We included all 15 HGNS patients. All patients had previously failed both CPAP and oral appliance therapy for sleep apnoea. Overnight polysomnography parameters were analysed before and at 1.5 years with HGNS. Results Mean +/- SD patient age was 53 +/- 6 years; 2 women and 13 men were included. Mean +/- SD efficient CPAP level was 11.4 +/- 3.4 cm H2O. Implantation technically succeeded in all patients. There were no significant changes of AHI and ODI4 after HGNS [median (quartile) 29.2/h (19.8-38.7) versus 30.1/h (15.6-52.6) and 15.0/h (5.9-20) versus 12.5/h (6.9-30.2) respectively]. Conclusion We did not observe significant changes in AHI and ODI4 indices with HGNS therapy. Larger multicentre randomised controlled trials are necessary before wider international use of HGNS.Peer reviewe

Influence of Motivational Text Messages on Adherence to Continuous Positive Airway Pressure Therapy

Obstructive sleep apnea (OSA) is a condition affecting an estimated 22% of men and 17% of women. Individuals with OSA have periodic bouts of apneas and hypopneas while sleeping that negatively impacts their sleep quality and neurohormonal function. As a result, individuals with OSA are at increased risk for diseases including diabetes, cancer, stroke, myocardial infarction, and depression. Continuous positive airway pressure (CPAP) therapy is an effective treatment for but adherence rates are low at an estimated 60%.The purpose of this pilot study was to examine the effects of a four-week text message-based intervention on an individual\u27s CPAP device adherence, OSA symptom management, and outcome expectations when compared to participants receiving generic text messages. Participants were randomized to an experimental group (EG) (n=29) or to a control group (CG) (n=28). The EG received one motivational text message every week for four weeks based on concepts derived from the theory of planned behavior (TPB). The CG received one text message every week for four weeks with objective information (average use in hours per week). Total mask-on time and CPAP adherence status were measured using CPAP device real-time data. Symptom management and CPAP use expectations were evaluated using Apnea Belief Scale (ABS), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10).There was no significant difference in total mask-on time between the two groups (p=.64). The proportion of participants classified as adherent did not differ between the two groups (p=.17). Differences in ABS, ESS, and FOSQ-10 scores between groups were also not significant (ANOVA, ABS: p =.47; ESS: p =.81; FOSQ: p =0.97).The pilot study identified trends toward improved CPAP adherence with use of TPB-based text messages. For example, the experimental group’s adherence rate was 14.8% higher than control group’s adherence rate. The lack of significance in the 3 instruments may have occurred because they measured actual behavior (CPAP use) and not what effect the intervention had on changing the behavior. More research is needed to elucidate the impact of TPB-based text messages on improving CPAP adherence and outcomes for individuals with OSA

Determining the prevalence and predictors of sleep disordered breathing in patients with chronic heart failure: rationale and design of the SCHLA-HF registry

BACKGROUND: The objective of the SCHLA-HF registry is to investigate the prevalence of sleep-disordered breathing (SDB) in patients with chronic heart failure with reduced left ventricular systolic function (HF-REF) and to determine predictors of SDB in such patients. METHODS: Cardiologists in private practices and in hospitals in Germany are asked to document patients with HF-REF into the prospective SCHLA-HF registry if they meet predefined inclusion and exclusion criteria. Screening was started in October 2007 and enrolment was completed at the end of May 2013. After enrolment in the registry, patients are screened for SDB. SDB screening is mainly undertaken using the validated 2-channel ApneaLink™ device (nasal flow and pulse oximetry; ResMed Ltd., Sydney, Australia). Patients with a significant number of apneas and hypopneas per hour recording time (AHI ≥15/h) and/or clinical symptoms suspicious of SDB will be referred to a cooperating sleep clinic for an attended in-lab polysomnography with certified scoring where the definite diagnosis and, if applicable, the differentiation between obstructive and central sleep apnea will be made. Suggested treatment will be documented. DISCUSSION: Registries play an important role in facilitating advances in the understanding and management of cardiovascular disease. The SCHLA-HF registry will provide consistent data on a large group of patients with HF-REF that will help to answer questions on the prevalence, risk factors, gender differences and stability of SDB in these patients by cross-sectional analyses. Further insight into the development of SDB will be gained by extension of the registry to include longitudinal data

A Panoramic Study of Obstructive Sleep Apnea Detection Technologies

This study offers a literature research reference value for bioengineers and practitioner medical doctors. It could reduce research time and improve medical service efficiency regarding Obstructive Sleep Apnea (OSA) detection systems. Much of the past and the current apnea research, the vital signals features and parameters of the SA automatic detection are introduced.The applications for the earlier proposed systems and the related work on real-time and continuous monitoring of OSA and the analysis is given. The study concludes with an assessment of the current technologies highlighting their weaknesses and strengths which can set a roadmap for researchers and clinicians in this rapidly developing field of study

Continuous Positive Airway Pressure Use and Mild Obstructive Sleep Apnea Syndrome (OSAS)

ABSTRACT CONTINUOUS POSITIVE AIRWAY PRESSURE USE AND MILD OBSTRUCTIVE SLEEP APNEA SYNDROME (OSAS) by Michelle L. Nelson The University of Wisconsin-Milwaukee, 2014 Under the Supervision of Jennifer Doering, PhD, RN Obstructive sleep apnea syndrome (OSAS) is an increasingly recognized sleep disorder that affects an estimated ten percent of middle-aged women and 25 percent of middle-aged men. Continuous positive airway pressure (CPAP) is the standard treatment for individuals with moderate to severe OSAS. However, it is estimated that 80 percent of individuals with OSAS have a milder form of the disease. The use of CPAP therapy in persons with mild OSAS has not been widely researched and whether CPAP is efficacious in this population remains inconclusive. OSAS has both psychological and physiological effects on people. Two common effects of CPAP use in persons with moderate and severe OSAS are reduced excessive daytime sleepiness (EDS) and reduced blood pressure. The purpose of this study was to examine the effectiveness of CPAP use on blood pressure and EDS in persons with mild OSAS. CPAP use was defined as using CPAP for more than 4 hours per night for more than 70 percent of nights recorded by the CPAP machine. The study design was a retrospective chart review of electronic medical records (EMR) from a sleep medicine clinic in the southeastern United States. The sample consisted of 60 participants with mild OSAS who were divided into two groups based upon the amount of CPAP use recorded in the EMR (4 or more hours of nightly use 70% of nights, n = 45 and less than 4 hours of nightly use 70% of nights, n = 15). Blood pressure (systolic and diastolic) and daytime sleepiness (Epworth Sleepiness Scale) data were collected on each participant before the initiation of CPAP therapy and at six weeks follow up. Independent samples t-tests were conducted to examine the differences between the groups from baseline to six-week follow-up on the outcome variables. No statistical significance was found for daytime sleepiness (t [34] = .865, p = .393) or either systolic (t [52] = .911, p = .367) or diastolic (t [52] = 1.002, p = .321) pressures. Sleepiness scores in the group who used CPAP four or more hours a night 70% of nights decreased 6.6 points from baseline to 6 weeks, and decreased 8.1 points in the group who used CPAP less than 4 hours a night 70% of the nights. Both groups experienced clinically significant decreases in daytime sleepiness from nearly excessive daytime sleepiness (ESS score \u3e10) before CPAP initiation to nearly no daytime sleepiness at six weeks follow up. There were significant limitations in data collection around both the EMR and the CPAP machine reporting that have implications for practice, research, and policy. Recommendations include standardization of CPAP use reporting across machine type and improving quality around data entry in the EMR. These results support the continued need to research the effectiveness of CPAP in persons with mild OSAS

The effect of therapy on arousal from sleep in patients with respiratory sleep disorders

Vibrotactile positional therapy (PT) is a relatively new treatment for positional obstructive sleep apnoea (POSA). It uses vibrotactile stimulus to encourage the sleeper to change position when supine. The overall aim of this thesis was to investigate the efficacy of vibrotactile PT as a clinical treatment for patients with POSA. To achieve this, different experimental approaches were used, including a systematic review and meta-analysis, a clinical trial, and a physiological study. The systematic review was carried out to evaluate the effect of vibrotactile PT on apnoea hypopnoea index (AHI), percentage of time spent in supine (%Tsupine), and patient-centred outcomes in patients with POSA compared to baseline. The results showed that vibrotactile PT was effective in reducing both AHI and %Tsupine. Although the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire minimally improved, these changes did not reach clinically important differences; however, limited data were found on quality of life (SF-36) vitality score. A prospective, three-month, multicentre, randomised, parallel, double-blind trial (The POSA Trial, ISRCTN51740863) was developed to investigate the effect of vibrotactile PT on AHI, quality of life and daytime functioning at follow-up, adjusted for the baseline, in patients with POSA compared to sham-vibrotactile PT. Baseline data (AHI, quality of life and daytime functioning) obtained from the participants recruited at the Royal Brompton Hospital are presented in the thesis. The mean baseline AHI for RBH participants was in the mild OSA category compared to the patients in the systematic review; however, a higher baseline %Tsupine was found. The baseline patient-centred outcomes were also comparable to those found in the systematic review. A physiological study in healthy participants (n=27) was carried out to investigate the effect of vibrotactile stimulus on arousability from sleep. A novel analysis method was developed to measure arousability. This included the duration from the vibrotactile stimulus to the position change using polysomnography. The results of this study showed heterogenous arousability responses to the vibrotactile stimulus with different phenotypes. Compared to males, healthy females took longer to respond to the vibrotactile stimulus and, therefore, were more resilient to arousability. In summary, the findings of this thesis have shown that vibrotactile PT devices are effective in treating patients with POSA. However, limited data on sensitive patient-centred outcomes exist. The POSA trial will provide data to address this evidence gap. Furthermore, the physiological findings in people without OSA showed that males are more arousable than females. This information may be of value when considering personalisation of clinical treatment. Future research of POSA will need to consider the arousability phenotype when planning treatment options.Open Acces