Sleep Apnea, ObstructiveLingualNCT03210142
Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)
A study testing Transvenous hypoglossal nerve stimulation in people with Sleep Apnea, Obstructive, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in Hong Kong.
Trial summary
The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause contraction of the genioglossus muscle, which will move the tongue forward, opening the upper-airway and reducing apnea-hypopnea events in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Transvenous hypoglossal nerve stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 3 sitesHong Kong
- Study dates
- 23 Jun 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject is at least 18 years old
- Subject is undergoing a standard new device implant, cardiac catheterization involving right heart catheterization and/or EP procedures
- Subject is able and willing to give informed consent
Who cannot join
- Subject is unable or unwilling to participate with study procedures
- Subject is pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to enrollment)
- Subject is known to be allergic to radio opaque dye
- Subject has a body mass index (BMI) >40 kg/m2
- Subject has had prior neck surgery that may interfere with vascular access to the lingual vein
- Subject has had prior surgery of the oral cavity that may interfere with tongue or soft palate movement
- Subject has a significant upper airway-related anatomic anomaly
- Subject is enrolled in a concurrent study that may confound the results of this study.
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Grantham Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
About this study
Official title: Minimally Invasive Hypoglossal Nerve Stimulation Study
The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause contraction of the genioglossus muscle, which will move the tongue forward, opening the upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that require an open surgical approach to wrap a cuff electrode around the HGN.
Read the detailed description
The primary objective is to determine the effect of tHGNS on tongue position in the upper airway in subjects undergoing an EP, cardiac catheterization or device procedure. (Measured as changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces.) This will be an acute study lasting no more than 45 min during a standard new device implant, cardiac catheterization and/or EP procedure. The hypoglossal nerve will be stimulated from the lingual vein using various stimulation parameters. Tongue motion, upper airway opening or any side effects will be recorded. At the end of the test procedure all hardware - the catheters, lead and/or guide wire will be removed.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Transvenous hypoglossal nerve stimulation
- Keywords
- Sleep Apnea, Neural Stimulation
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvenous hypoglossal nerve stimulationProcedure or surgery
Transvenous hypoglossal nerve stimulation to open upper airway.
| Study group | Role | What they receive |
|---|---|---|
| Transvenous hypoglossal nerve stimulation | Experimental | Transvenous hypoglossal nerve stimulation for subjects undergoing an EP, cardiac catheterization or device procedure. Receives: Procedure: Transvenous hypoglossal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of transvenous hypoglossal nerve stimulation on tongue position
Measured in changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces from lateral fluoroscopic images.
Measured: During study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start23 Jun 2017
- Primary completion8 Feb 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210142
- Sponsor's protocol ID
- MDT16057
- Acronym
- Lingual
- Status last verified
- Aug 2018
- First submitted
- 14 Jun 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Hypoglossal Nerve Stimulation Study
- ClinicalTrials.gov ID
- NCT03210142
- Acronym / sponsor ID
- Lingual / MDT16057
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep Apnea, Neural Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of Transvenous Hypoglossal Nerve Stimulation (tHGNS) on tongue position in the upper airway. Activation of the HGN will cause contraction of the genioglossus muscle, which will move the tongue forward, opening the upper-airway and reducing apnea-hypopnea events in patients with Obstructive Sleep Apnea (OSA). A transvenous approach will be less risky and traumatic than current HGNS systems that require an open surgical approach to wrap a cuff electrode around the HGN.
Detailed description
The primary objective is to determine the effect of tHGNS on tongue position in the upper airway in subjects undergoing an EP, cardiac catheterization or device procedure. (Measured as changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces.) This will be an acute study lasting no more than 45 min during a standard new device implant, cardiac catheterization and/or EP procedure. The hypoglossal nerve will be stimulated from the lingual vein using various stimulation parameters. Tongue motion, upper airway opening or any side effects will be recorded. At the end of the test procedure all hardware - the catheters, lead and/or guide wire will be removed.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transvenous hypoglossal nerve stimulation | Experimental | Procedure: Transvenous hypoglossal nerve stimulationTransvenous hypoglossal nerve stimulation for subjects undergoing an EP, cardiac catheterization or device procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is at least 18 years old
- Subject is undergoing a standard new device implant, cardiac catheterization involving right heart catheterization and/or EP procedures
- Subject is able and willing to give informed consent
Key exclusion criteria (8 listed)
- Subject is unable or unwilling to participate with study procedures
- Subject is pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to enrollment)
- Subject is known to be allergic to radio opaque dye
- Subject has a body mass index (BMI) >40 kg/m2
- Subject has had prior neck surgery that may interfere with vascular access to the lingual vein
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 |
|---|---|---|
| Transvenous hypoglossal nerve stimulationTransvenous hypoglossal nerve stimulation to open upper airway. | Procedure or surgery | Transvenous hypoglossal nerve stimulation |
Primary outcome
Effect of transvenous hypoglossal nerve stimulation on tongue position
Time frame: During study procedure
Measured in changes in the anteroposterior dimensions (2-dimensional) of the retropalatal and retrolingual airway spaces from lateral fluoroscopic images.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvenous hypoglossal nerve stimulation in people with Sleep Apnea, Obstructive, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in Hong Kong.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of transvenous hypoglossal nerve stimulation on tongue position (time frame: During study procedure). 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 17 Aug 2018.