Obstructive Sleep ApneaNCT03051165
Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea
A study testing Hypoglossal Nerve Stimulation Treatment Withdrawal in people with Obstructive Sleep Apnea, run by Emory University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Hypoglossal Nerve Stimulation Treatment Withdrawal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to 14 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active smokers
- Unstable and untreated coronary or peripheral artery disease
- Use of alpha-blockers
- Severe and inadequately controlled arterial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Hypoglossal Nerve Stimulation Treatment Withdrawal
- Keywords
- Cardiovascular Disease, Pulmonary Medicine, Hypoglossal Nerve Stimulation
- Medical subject headings
- Sleep Apnea, Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal Nerve Stimulation Treatment WithdrawalDevice
Also called HGNS
After 90 days of hypoglossal nerve stimulation (HGNS), therapy will be discontinued for 30 days before being reactivated.
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal Nerve Stimulation Treatment Withdrawal | Other | Recipients of hypoglossal nerve stimulation (HGNS) who agree to participate in the study will have additional tests done to monitor cardiovascular responses to HGNS therapy and the temporary withdrawal of treatment. Receives: Device: Hypoglossal Nerve Stimulation Treatment Withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peripheral Arterial Tonometry (PAT)
Peripheral arterial tonometry (PAT) is a method for measuring endothelial dysfunction in a non-invasive way. Blood flow is measured in the fingertips following compression with an inflatable cuff on the upper arm. Participants will lay on their backs with a probe placed on the finger of each hand. The probes are attached to a computer that records finger blood flow. The finger probes will continuously record the blood flow in the fingertips for 10 minutes
Measured: Baseline, Day 105, Day 137
Secondary outcomes (8)
Change in Flow Mediated Dilation
Flow mediated dilation is a method to assess endothelial function using an ultrasound device to take measurements of the artery at the elbow. Blood vessel diameter is measured before and after blood pressure cuff release and flow mediated dilation is the percent of change between the baseline and post cuff release measurements. A lower measurement of dilation corresponds with an increased risk for cardiovascular events.
Measured: Baseline, Day 105, Day 137
Change in Peripheral Arterial Stiffness
Recordings of blood flow through the artery in the wrist will be obtained with application of a probe applied to the skin. Participants will be seated or lying down for this test which takes approximately 10 minutes. Increased arterial stiffness is associated with an increased risk of cardiovascular events.
Measured: Baseline, Day 105, Day 137
Change in 24-hour Ambulatory Blood Pressure
To measure 24-hour ambulatory blood pressure, participants wear a watch like device on one arm which records blood pressure throughout the day.
Measured: Baseline, Day 105, Day 137
Change in C-reactive Protein
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. C-reactive protein is produced by the liver and increased concentrations are found when inflammation is present in the body.
Measured: Baseline, Day 105, Day 137
Change in Fibrin Degradation Products
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Fibrin degradation products are produced by of clot degeneration. Plasma fibrin degradation products increase following clot formation.
Measured: Baseline, Day 105, Day 137
Change in Heat Shock Protein 70 (HSP70)
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Heat shock protein 70 (HSP70) is a stress protein. Heat shock proteins increase in response to stress conditions such as inflammation and infection.
Measured: Baseline, Day 105, Day 137
Change in High Sensitivity Cardiac Troponin (HS-troponin)
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Elevated high sensitivity cardiac troponin (HS-troponin) indicates injury to the heart.
Measured: Baseline, Day 105, Day 137
Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR)
To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Soluble urokinase-type plasminogen activator receptor (suPAR) is a marker for disease status by indicating the degree of activation of the immune system. Higher concentrations indicate inflammation and are associated with an increased risk of mortality.
Measured: Baseline, Day 105, Day 137
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start21 Nov 2016
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Why it stopped: Study was terminated due to funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo the intervention of temporary treatment withdrawal to examine cardiac measurements before treatment, during treatment, and after cessation.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Dedhia, Emory University
- Investigators
- Raj Dedhia, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051165
- Sponsor's protocol ID
- IRB00088693
- Status last verified
- Nov 2018
- First submitted
- 9 Feb 2017
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upper Airway Stimulation on Vascular Function in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03051165
- Acronym / sponsor ID
- IRB00088693
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Cardiovascular Disease, Pulmonary Medicine, Hypoglossal Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to funding issues.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo the intervention of temporary treatment withdrawal to examine cardiac measurements before treatment, during treatment, and after cessation.
| Arm | Type | Receives |
|---|---|---|
| Hypoglossal Nerve Stimulation Treatment Withdrawal | Other | Device: Hypoglossal Nerve Stimulation Treatment WithdrawalRecipients of hypoglossal nerve stimulation (HGNS) who agree to participate in the study will have additional tests done to monitor cardiovascular responses to HGNS therapy and the temporary withdrawal of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- Active smokers
- Unstable and untreated coronary or peripheral artery disease
- Use of alpha-blockers
- Severe and inadequately controlled arterial hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglossal Nerve Stimulation Treatment WithdrawalAlso: HGNSAfter 90 days of hypoglossal nerve stimulation (HGNS), therapy will be discontinued for 30 days before being reactivated. | Device | Hypoglossal Nerve Stimulation Treatment Withdrawal |
Primary outcome
Change in Peripheral Arterial Tonometry (PAT)
Time frame: Baseline, Day 105, Day 137
Peripheral arterial tonometry (PAT) is a method for measuring endothelial dysfunction in a non-invasive way. Blood flow is measured in the fingertips following compression with an inflatable cuff on the upper arm. Participants will lay on their backs with a probe placed on the finger of each hand. The probes are attached to a computer that records finger blood flow. The finger probes will continuously record the blood flow in the fingertips for 10 minutes
8 secondary outcomes
Change in Flow Mediated Dilation
Time frame: Baseline, Day 105, Day 137
Change in Peripheral Arterial Stiffness
Time frame: Baseline, Day 105, Day 137
Change in 24-hour Ambulatory Blood Pressure
Time frame: Baseline, Day 105, Day 137
Change in C-reactive Protein
Time frame: Baseline, Day 105, Day 137
Change in Fibrin Degradation Products
Time frame: Baseline, Day 105, Day 137
Change in Heat Shock Protein 70 (HSP70)
Time frame: Baseline, Day 105, Day 137
Change in High Sensitivity Cardiac Troponin (HS-troponin)
Time frame: Baseline, Day 105, Day 137
Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR)
Time frame: Baseline, Day 105, Day 137
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Dedhia, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglossal Nerve Stimulation Treatment Withdrawal in people with Obstructive Sleep Apnea, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peripheral Arterial Tonometry (PAT) (time frame: Baseline, Day 105, Day 137). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.