Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/13/2018 |
| Start Date: | November 21, 2016 |
| End Date: | December 14, 2017 |
This study will evaluate the effect of hypoglossal nerve stimulation (HGNS) on different
measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People
with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study
site will be told about the study at their 2-week post-operative appointment. Those who
decide to participate will have blood drawn and vascular function measurements taken before
HGNS activation, during treatment, and after a temporary treatment withdrawal period.
Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.
measures of cardiovascular function in patients with obstructive sleep apnea (OSA). People
with OSA who have undergone implantation of the hypoglossal nerve stimulator at the study
site will be told about the study at their 2-week post-operative appointment. Those who
decide to participate will have blood drawn and vascular function measurements taken before
HGNS activation, during treatment, and after a temporary treatment withdrawal period.
Following the 30-day period of treatment withdrawal, the HGNS therapy will be reactivated.
Obstructive sleep apnea (OSA), the repetitive collapse of the upper airway during sleep,
represents a growing individual and public health concern. This disease negatively impacts
patients' sleep quality and daytime function, including an increased risk of motor vehicle
accidents. Several large, longitudinal cohorts have consistently demonstrated deleterious
effects of OSA on cardiovascular health, including elevated rates of incident hypertension,
myocardial infarction and cerebrovascular accidents. The link between OSA and cardiovascular
consequences can be largely explained by autonomic imbalance during repeated episodes of
nocturnal airway obstruction. Compared to those without OSA, people with OSA have increased
sympathetic activity when awake, with further elevation of both sympathetic activity and
blood pressure during sleep. Multiple physiologic mechanisms are responsible for these
autonomic changes during obstructive episodes including the interaction of baroreceptors,
chemoreceptors and respiratory afferent receptors.
Positive airway pressure (PAP) serves as a pneumatic stent for the airway, maintaining airway
patency and normoxia. PAP therapy has demonstrated consistent, meaningful reductions in
sympathetic overactivity during wake and sleep. Although PAP therapy is highly efficacious,
fewer than 50% of patients are adequately treated due to adherence difficulty. In 2014, the
Federal Drug Administration approved hypoglossal nerve stimulation (HGNS) for the treatment
of patients with moderate-severe OSA who are unable to adequately use PAP. This therapy has
demonstrated stable, marked improvement in key polysomnography indices, sleepiness measures
and functional outcomes, however, no study has examined cardiovascular endpoints of HGNS
therapy in OSA patients.
The aim of this study is to evaluate the effect of HGNS therapy on autonomic and vascular
function before, during and after treatment for OSA with HGNS. People who have undergone
implantation of the hypoglossal nerve stimulator at the study site will be told about the
study at their 2-week post-operative appointment. Those who decide to participate in the
study will have blood drawn and vascular function measurements taken before the HGNS device
is activated, during treatment, and after a temporary treatment withdrawal period. The
researchers hypothesize that all aforementioned measurements will be significantly improved
following HGNS therapy and return to baseline values following a therapy withdrawal period.
represents a growing individual and public health concern. This disease negatively impacts
patients' sleep quality and daytime function, including an increased risk of motor vehicle
accidents. Several large, longitudinal cohorts have consistently demonstrated deleterious
effects of OSA on cardiovascular health, including elevated rates of incident hypertension,
myocardial infarction and cerebrovascular accidents. The link between OSA and cardiovascular
consequences can be largely explained by autonomic imbalance during repeated episodes of
nocturnal airway obstruction. Compared to those without OSA, people with OSA have increased
sympathetic activity when awake, with further elevation of both sympathetic activity and
blood pressure during sleep. Multiple physiologic mechanisms are responsible for these
autonomic changes during obstructive episodes including the interaction of baroreceptors,
chemoreceptors and respiratory afferent receptors.
Positive airway pressure (PAP) serves as a pneumatic stent for the airway, maintaining airway
patency and normoxia. PAP therapy has demonstrated consistent, meaningful reductions in
sympathetic overactivity during wake and sleep. Although PAP therapy is highly efficacious,
fewer than 50% of patients are adequately treated due to adherence difficulty. In 2014, the
Federal Drug Administration approved hypoglossal nerve stimulation (HGNS) for the treatment
of patients with moderate-severe OSA who are unable to adequately use PAP. This therapy has
demonstrated stable, marked improvement in key polysomnography indices, sleepiness measures
and functional outcomes, however, no study has examined cardiovascular endpoints of HGNS
therapy in OSA patients.
The aim of this study is to evaluate the effect of HGNS therapy on autonomic and vascular
function before, during and after treatment for OSA with HGNS. People who have undergone
implantation of the hypoglossal nerve stimulator at the study site will be told about the
study at their 2-week post-operative appointment. Those who decide to participate in the
study will have blood drawn and vascular function measurements taken before the HGNS device
is activated, during treatment, and after a temporary treatment withdrawal period. The
researchers hypothesize that all aforementioned measurements will be significantly improved
following HGNS therapy and return to baseline values following a therapy withdrawal period.
Inclusion Criteria:
- English-speaking
- Able to give informed consent
- Have undergone implantation of hypoglossal nerve stimulator (HGNS) by the principal
investigator of this study. HGNS inclusion criteria per FDA are as follows:
- Apnea-hypopnea index (AHI) of 20 or more from recent sleep test
- Unable to use positive airway pressure therapy
- Body Mass Index (BMI) < 32 kg/m2
- Without circumferential collapse on drug-induced sedated endoscopy
Exclusion Criteria:
- Active smokers
- Unstable and untreated coronary or peripheral artery disease
- Use of alpha-blockers
- Severe and inadequately controlled arterial hypertension
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