Obstructive Sleep ApneaNCT06154577
Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy
An observational study of Obstructive Sleep Apnea and Sleep-Disordered Breathing, run by Cantonal Hospital, Baselland at 2 sites in Switzerland.
Trial summary
Hypoglossal nerve stimulation (HNS) plays an increasingly important role in managing patients with obstructive sleep apnea (OSA) who do not tolerate CPAP therapy and are not eligible for other alternative treatment options, such as mandibular advancement devices or positional therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep-Disordered Breathing
- What is being tested?
- Ultrasonography
- How many people
- 65 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 15 May 2023to 29 May 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 39 obstructive sleep apnea patients with hypoglossal nerve stimulation and 15 subjects in the control group
Who may be able to join
- Patients older than 18 year
- patients with a hypoglossal nerve implantation
- control group: 15 subjects without OSA (AHI<10/h)
- written informed consent
- sufficient knowledge of German or French to understand informed consent
Who cannot join
- Patients younger than 18 years
- unwillingness to give informed consent
- incapable of performing Müller's maneuver
- history of head and neck surgery other than HNS, tonsillectomy, and maxillomandibular advancement
- diagnosis of congestive heart failure or chronic pulmonary disease
- diagnosis of co-morbid sleep disorders, including central sleep apnea
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Bern, Inselspital
Bern, 3010
Kantonsspital Baselland
Liestal, Basel-Landschaft, 4410
About this study
Hypoglossal nerve stimulation (HNS) plays an increasingly important role in managing patients with obstructive sleep apnea (OSA) who do not tolerate CPAP therapy and are not eligible for other alternative treatment options, such as mandibular advancement devices or positional therapy. The posterior upper airway space dimensions are crucial in managing patients with HNS in the patient selection process and therapy control. The lateral collapse of the upper airway is of crucial importance. Lateral collapse at the palatal level and of the oropharyngeal walls is a well-established negative predictive factor for therapeutic success. Patients with complete concentric collapse at the palatal level (pCCC) in drug-induced sedation endoscopy (DISE) must be excluded from the implantation of HNS, which is cumbersome and invasive. Endoscopy has the inherent limitation that only one level can be observed at a given time, and assessment is possibly hampered by phlegm.
During activation and titration of HNS, tongue protrusion is observed in the awake patient. However, this method does not allow for assessing the opening of the retroglossal (RG) and retropalatal (RP) airway space, which is the ultimate therapeutic goal. Insufficient opening of the airway is the reason for non-responders with HNS. Insufficient upper airway opening can be either at the retropalatal or retroglossal level. The study aims to identify insufficient airway openings better using sub-mental ultrasonography. Sub-mental standardized and orientated ultrasonography offers a quantitative, reproducible way of assessing transverse upper airway dimensions and anatomic features of the upper airway in a rapid and non-invasive manner. In addition, anatomic characteristics of the airway's adjacent tissue, such as the size and shape of the tongue, may also have an impact on the effectiveness of HNS. Tongue morphology and posterior airway space assessment could be used in preoperative evaluation and during therapeutic titration of HNS. The clinical routine could be included tongue morphology and posterior airway space assessment without additional patient risks. However, the clinical value of assessing posterior airway space and tongue morphology in patients with HNS is yet unknown.
- Being tested
- Ultrasonography
- Keywords
- hypoglossal nerve stimulation, ultrasonography
- 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.
UltrasonographyDiagnostic test
Assessment of tongue morphology and posterior airway space using ultrasonography (AmCAD-UO, CE mark NB1639)
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea patients | 39 obstructive sleep apnea patients with hypoglossal nerve stimulation Receives: Diagnostic Test: Ultrasonography | |
| Healthy controls | 15 healthy control participants Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of therapeutic success with hypoglossal nerve stimulation
Success is defined as apnea-hypopnea index in the most recent sleep testing ≤ 20/h and 50% reduction from baseline
Measured: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
Secondary outcomes (6)
Prediction of AHI reduction, defined as the difference between pre- and postoperative AHI, with HNS based on tongue morphology and posterior airway space.
AHI reduction is defined as apnea-hypopnea index in the most recent sleep compared to the baseline value before HNS implantation
Measured: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
Comparison of pharyngeal dimensions between visual assessment and tongue morphology and posterior airway space
Visual assessment is performed both by DISE and wake transnasal endoscopy. Tongue morphology and posterior airway space is analyzed using ultrasonography
Measured: through study completion, from 15.05.2023 to 14.05.2024
Therapeutical guidance using tongue morphology and posterior airway space to identify the obstructing upper airway segment compared to wake fiberoptic endoscopy during HGS in non-responders.
Changes to therapeutic HNS settings during study visit
Measured: through study completion, from 15.05.2023 to 14.05.2024
Patient comfort rated by the patients for wake transnasal endoscopy and sub-mental ultrasonography
Rated on a visual analog scale (VAS) from 0 to 10 (0 meaning no discomfort; 10 meaning very uncomfortable
Measured: through study completion, from 15.05.2023 to 14.05.2024
Information gain through from tongue morphology and posterior airway space imaging
Rating by the physician if the additional information gained from tongue morphology and posterior airway space imaging at functional stimulation threshold is a valuable adjunct to the oral observation of tongue protrusion rated on a VAS
Measured: through study completion, from 15.05.2023 to 14.05.2024
Comparison of pharyngeal dimensions of healthy and patients with OSA and HNS
Pharyngeal dimensions measured using ultrasonography
Measured: through study completion, from 15.05.2023 to 14.05.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start15 May 2023
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154577
- Sponsor's protocol ID
- 2023-00117
- Other IDs
- 2023
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tschopp S, Janjic V, Caversaccio M, Borner U, Tschopp K. Ultrasonographic Tongue Base Motion Does Not Correlate With Hypoglossal Nerve Stimulation Outcomes. Laryngoscope Investig Otolaryngol. 2026 Mar 10;11(2):e70376. doi: 10.1002/lio2.70376. eCollection 2026 Apr.
PubMed 41821851Tschopp S, Janjic V, Lee Y, Chen A, Chao PY, Caversaccio M, Borner U, Tschopp K. Backscattered Ultrasonographic Imaging of the Tongue and Outcome in Hypoglossal Nerve Stimulation. Otolaryngol Head Neck Surg. 2025 Jun;172(6):2134-2140. doi: 10.1002/ohn.1251. Epub 2025 Apr 7.
PubMed 40192006
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy
- ClinicalTrials.gov ID
- NCT06154577
- Acronym / sponsor ID
- 2023-00117
- Keywords
- hypoglossal nerve stimulation, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- 15 May 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 4 Dec 2023 (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.
Hypoglossal nerve stimulation (HNS) plays an increasingly important role in managing patients with obstructive sleep apnea (OSA) who do not tolerate CPAP therapy and are not eligible for other alternative treatment options, such as mandibular advancement devices or positional therapy. The posterior upper airway space dimensions are crucial in managing patients with HNS in the patient selection process and therapy control. The lateral collapse of the upper airway is of crucial importance. Lateral collapse at the palatal level and of the oropharyngeal walls is a well-established negative predictive factor for therapeutic success. Patients with complete concentric collapse at the palatal level (pCCC) in drug-induced sedation endoscopy (DISE) must be excluded from the implantation of HNS, which is cumbersome and invasive. Endoscopy has the inherent limitation that only one level can be observed at a given time, and assessment is possibly hampered by phlegm.
During activation and titration of HNS, tongue protrusion is observed in the awake patient. However, this method does not allow for assessing the opening of the retroglossal (RG) and retropalatal (RP) airway space, which is the ultimate therapeutic goal. Insufficient opening of the airway is the reason for non-responders with HNS. Insufficient upper airway opening can be either at the retropalatal or retroglossal level. The study aims to identify insufficient airway openings better using sub-mental ultrasonography. Sub-mental standardized and orientated ultrasonography offers a quantitative, reproducible way of assessing transverse upper airway dimensions and anatomic features of the upper airway in a rapid and non-invasive manner. In addition, anatomic characteristics of the airway's adjacent tissue, such as the size and shape of the tongue, may also have an impact on the effectiveness of HNS. Tongue morphology and posterior airway space assessment could be used in preoperative evaluation and during therapeutic titration of HNS. The clinical routine could be included tongue morphology and posterior airway space assessment without additional patient risks. However, the clinical value of assessing posterior airway space and tongue morphology in patients with HNS is yet unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea patients | – | Diagnostic Test: Ultrasonography39 obstructive sleep apnea patients with hypoglossal nerve stimulation |
| Healthy controls | – | Diagnostic Test: Ultrasonography15 healthy control participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 39 obstructive sleep apnea patients with hypoglossal nerve stimulation and 15 subjects in the control group
Key inclusion criteria (5 listed)
- Patients older than 18 year
- patients with a hypoglossal nerve implantation
- control group: 15 subjects without OSA (AHI<10/h)
- written informed consent
- sufficient knowledge of German or French to understand informed consent
Key exclusion criteria (7 listed)
- Patients younger than 18 years
- unwillingness to give informed consent
- incapable of performing Müller's maneuver
- history of head and neck surgery other than HNS, tonsillectomy, and maxillomandibular advancement
- diagnosis of congestive heart failure or chronic pulmonary disease
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 |
|---|---|---|
| UltrasonographyAssessment of tongue morphology and posterior airway space using ultrasonography (AmCAD-UO, CE mark NB1639) | Diagnostic test | Healthy controls, Obstructive sleep apnea patients |
Primary outcome
Prediction of therapeutic success with hypoglossal nerve stimulation
Time frame: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
Success is defined as apnea-hypopnea index in the most recent sleep testing ≤ 20/h and 50% reduction from baseline
6 secondary outcomes
Prediction of AHI reduction, defined as the difference between pre- and postoperative AHI, with HNS based on tongue morphology and posterior airway space.
Time frame: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination
Comparison of pharyngeal dimensions between visual assessment and tongue morphology and posterior airway space
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Therapeutical guidance using tongue morphology and posterior airway space to identify the obstructing upper airway segment compared to wake fiberoptic endoscopy during HGS in non-responders.
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Patient comfort rated by the patients for wake transnasal endoscopy and sub-mental ultrasonography
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Information gain through from tongue morphology and posterior airway space imaging
Time frame: through study completion, from 15.05.2023 to 14.05.2024
Comparison of pharyngeal dimensions of healthy and patients with OSA and HNS
Time frame: through study completion, from 15.05.2023 to 14.05.2024
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 5 Jun 2024.
- Derived from this study: PubMed 41821851Tschopp S, Janjic V, Caversaccio M, Borner U, Tschopp K. Ultrasonographic Tongue Base Motion Does Not Correlate With Hypoglossal Nerve Stimulation Outcomes. Laryngoscope Investig Otolaryngol. 2026 Mar 10;11(2):e70376. doi: 10.1002/lio2.70376. eCollection 2026 Apr.
- Derived from this study: PubMed 40192006Tschopp S, Janjic V, Lee Y, Chen A, Chao PY, Caversaccio M, Borner U, Tschopp K. Backscattered Ultrasonographic Imaging of the Tongue and Outcome in Hypoglossal Nerve Stimulation. Otolaryngol Head Neck Surg. 2025 Jun;172(6):2134-2140. doi: 10.1002/ohn.1251. Epub 2025 Apr 7.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Sleep-Disordered Breathing, run by Cantonal Hospital, Baselland at 2 sites in Switzerland.
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 5 inclusion and 7 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 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Prediction of therapeutic success with hypoglossal nerve stimulation (time frame: Most recent sleep testing before examination after HNS implantation, a maximum of 6 months before examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06154577, which also lists 2 linked publications.
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 5 Jun 2024.