Date of Award

Spring 2021

Degree Name

Master of Medical Science (Physician Assistant)

Department

Physician Assistant; College of Health Sciences

First Advisor

Kaitlyn Gamber

Abstract

Introduction: Obstructive sleep apnea is a prevalent sleep disorder affecting millions of Americans each year, defined by intermittent episodes of apnea during sleep. Treatment adherence to the CPAP machine, which is currently the standard of care, remains at a staggeringly low percentage due to various reasons. As a result, this paper aims to ascertain if the novel hypoglossal nerve stimulator (I) is a more suitable option for the treatment of OSA (O) than CPAP (C), in patients with moderate to severe OSA, aged 45-75 (P).

Methods: A literature search was conducted on PubMed and ClinicalKey, eliciting 7 scholarly articles in November 2019. These articles consisted of randomized controlled trials and prospective cohort studies and were picked on the criteria of publication date, sample population and size, and duration of trial. Each of the 7 articles’ study designs and results were critically analyzed.

Results: Each of the five articles that studied the outcomes of the hypoglossal nerve stimulator seemed to provide promising results for the future of the therapy. OSA measured outcomes such as AHI, ODI, and ESS initially decreased, however, in the majority of the studies long term benefits seemed to wane. Many of the trials provided high adverse event occurrence rates, with short-term follow up periods. The two articles proposing alterations to the CPAP therapy provided significant results in terms of creating a greater adherence rate to the treatment.

Discussion: Small sample sizes and short follow up periods were some of the limitations that many of the trials faced. Sample populations need to be diversified to accurately reflect the majority of patients who suffer from this disease. High adverse event occurrences make the safety of the device questionable. Due to study design flaws and patient dropout, 6/7 of the studies were considered to have varying amounts of bias which could skew the results. Overall, 4 of the 7 articles provided significant results.

Conclusion: Despite promising preliminary trials, the hypoglossal nerve stimulator cannot currently be recommended as a replacement of the CPAP machine in the treatment of moderate to severe OSA. Waning efficacy of the device at follow ups and a high percentage of adverse events are two of the main deterrents of recommending that this therapy is the new gold standard treatment. Further research into the hypoglossal nerve stimulator with larger studies and longer follow up periods is warranted for the possibility of a future standard of care recommendation.

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Efficacy and Safety of the Hypoglossal Nerve Stimulator Compared to Continuous Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea in Patients Aged 45-75

Introduction: Obstructive sleep apnea is a prevalent sleep disorder affecting millions of Americans each year, defined by intermittent episodes of apnea during sleep. Treatment adherence to the CPAP machine, which is currently the standard of care, remains at a staggeringly low percentage due to various reasons. As a result, this paper aims to ascertain if the novel hypoglossal nerve stimulator (I) is a more suitable option for the treatment of OSA (O) than CPAP (C), in patients with moderate to severe OSA, aged 45-75 (P).

Methods: A literature search was conducted on PubMed and ClinicalKey, eliciting 7 scholarly articles in November 2019. These articles consisted of randomized controlled trials and prospective cohort studies and were picked on the criteria of publication date, sample population and size, and duration of trial. Each of the 7 articles’ study designs and results were critically analyzed.

Results: Each of the five articles that studied the outcomes of the hypoglossal nerve stimulator seemed to provide promising results for the future of the therapy. OSA measured outcomes such as AHI, ODI, and ESS initially decreased, however, in the majority of the studies long term benefits seemed to wane. Many of the trials provided high adverse event occurrence rates, with short-term follow up periods. The two articles proposing alterations to the CPAP therapy provided significant results in terms of creating a greater adherence rate to the treatment.

Discussion: Small sample sizes and short follow up periods were some of the limitations that many of the trials faced. Sample populations need to be diversified to accurately reflect the majority of patients who suffer from this disease. High adverse event occurrences make the safety of the device questionable. Due to study design flaws and patient dropout, 6/7 of the studies were considered to have varying amounts of bias which could skew the results. Overall, 4 of the 7 articles provided significant results.

Conclusion: Despite promising preliminary trials, the hypoglossal nerve stimulator cannot currently be recommended as a replacement of the CPAP machine in the treatment of moderate to severe OSA. Waning efficacy of the device at follow ups and a high percentage of adverse events are two of the main deterrents of recommending that this therapy is the new gold standard treatment. Further research into the hypoglossal nerve stimulator with larger studies and longer follow up periods is warranted for the possibility of a future standard of care recommendation.