Sleep Apnea, ObstructiveNCT05429983
Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics
An observational study of Sleep Apnea, Obstructive, run by Johns Hopkins University at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 29 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Participants will be those undergoing drug-induced sleep endoscopy as part of routine clinical care for work up hypoglossal nerve stimulation therapy candidacy. All participants will have a confirmed diagnosis of obstructive sleep apnea with an apnea-hypopnea index >15 and deemed to be intolerant of continuous positive airway pressure.
Who may be able to join
- Male and female participants with moderate or severe sleep apnea (defined by > 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy.
Who cannot join
- Significant cardiac disease, unstable or recent cardiac events
- Active pulmonary, liver or renal disease
- Uncontrolled hypertension (BP>160/100)
- Neuromuscular disease
- Major psychiatric disease
- Pregnancy
- Anticoagulation therapy (e.g. Coumadin, Dabigatran)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Kevin M Motz, MD, 301-992-1779, kmotz1@jhmi.edu
About this study
Official title: Assessing Stimulated Upper Airway Mechanics to Predict Outcomes in Hypoglossal Nerve
Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Inspire™ is an FDA-approved hypoglossal nerve stimulation device (HGNS) used in select patients with OSA who are intolerant of CPAP. The device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. Despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to HGNS and remain at risk for complications from untreated OSA. The current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to HGNS therapy.
Drug induced sleep endoscopy (DISE) is a prerequisite for HGNS treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. The amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of OSA with HGNS. As a result, CPAP titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of DISE to select parties for HGNS at multiple institutions. Nevertheless, changes in upper airway collapsibility in response HGNS may differ significantly between patients. This stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of DISE predicts successful treatment with HGNS as defined by a 50% reduction on apnea-hypopnea index (AHI) and an on-treatment AHI <20.
- Conditions
- Sleep Apnea, Obstructive
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypoglossal Nerve Stimulation Candidates | Participants will have a diagnosis of obstructive sleep apnea and have failed treatment with continuous positive airway pressure (CPAP). Participants will be those undergoing drug-induced sleep endoscopy (DISE) as part of routine clinical care for work up of hypoglossal nerve stimulation candidacy as a treatment for obstructive sleep apnea. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal airflow with direct genioglossus stimulation
Tidal airflow (mL) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.
Measured: at the time of drug-induced sleep endoscopy, up to 1 hour
HGNS therapy success as assessed by the apnea hypopnea index
Successful treatment with HGNS, as defined by a 50% reduction in apnea hypopnea index (AHI) and an on-therapy AHI of <15 (the same criteria as in major trials of non-CPAP OSA treatment).
Measured: at 1 year post HGNS implantation
Secondary outcomes (2)
Therapeutic CPAP pressure with direct genioglossus stimulation
Therapeutic CPAP pressure (cmH20) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.
Measured: At the time of drug-induced sleep endoscopy, up to 1 hour
Airway critical closing pressure with direct genioglossus stimulation
Airway critical closing pressure (cmH20) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.
Measured: At the time of drug-induced sleep endoscopy, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start29 Nov 2022
- Primary completion29 Nov 2027 (estimated)
- Study completion29 Nov 2028 (estimated)
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.
- More trials run by Johns Hopkins 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Kevin Motz, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429983
- Sponsor's protocol ID
- IRB00319723
- Other IDs
- 278-jf-22
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2022
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Stimulated Upper Airway Mechanics to Predict Outcomes in Hypoglossal Nerve
- ClinicalTrials.gov ID
- NCT05429983
- Acronym / sponsor ID
- IRB00319723
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 29 Nov 2028 (estimated)
- First posted
- 24 Jun 2022 (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.
Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Inspire™ is an FDA-approved hypoglossal nerve stimulation device (HGNS) used in select patients with OSA who are intolerant of CPAP. The device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. Despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to HGNS and remain at risk for complications from untreated OSA. The current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to HGNS therapy.
Drug induced sleep endoscopy (DISE) is a prerequisite for HGNS treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. The amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of OSA with HGNS. As a result, CPAP titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of DISE to select parties for HGNS at multiple institutions. Nevertheless, changes in upper airway collapsibility in response HGNS may differ significantly between patients. This stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of DISE predicts successful treatment with HGNS as defined by a 50% reduction on apnea-hypopnea index (AHI) and an on-treatment AHI <20.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoglossal Nerve Stimulation Candidates | – | –Participants will have a diagnosis of obstructive sleep apnea and have failed treatment with continuous positive airway pressure (CPAP). Participants will be those undergoing drug-induced sleep endoscopy (DISE) as part of routine clinical care for work up of hypoglossal nerve stimulation candidacy as a treatment for obstructive sleep apnea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be those undergoing drug-induced sleep endoscopy as part of routine clinical care for work up hypoglossal nerve stimulation therapy candidacy. All participants will have a confirmed diagnosis of obstructive sleep apnea with an apnea-hypopnea index >15 and deemed to be intolerant of continuous positive airway pressure.
Key inclusion criteria (1 listed)
- Male and female participants with moderate or severe sleep apnea (defined by > 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy.
Key exclusion criteria (7 listed)
- Significant cardiac disease, unstable or recent cardiac events
- Active pulmonary, liver or renal disease
- Uncontrolled hypertension (BP>160/100)
- Neuromuscular disease
- Major psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tidal airflow with direct genioglossus stimulation
Time frame: at the time of drug-induced sleep endoscopy, up to 1 hour
Tidal airflow (mL) with direct stimulation of the genioglossus muscle will be measured at the time of drug-induced sleep endoscopy.
HGNS therapy success as assessed by the apnea hypopnea index
Time frame: at 1 year post HGNS implantation
Successful treatment with HGNS, as defined by a 50% reduction in apnea hypopnea index (AHI) and an on-therapy AHI of <15 (the same criteria as in major trials of non-CPAP OSA treatment).
2 secondary outcomes
Therapeutic CPAP pressure with direct genioglossus stimulation
Time frame: At the time of drug-induced sleep endoscopy, up to 1 hour
Airway critical closing pressure with direct genioglossus stimulation
Time frame: At the time of drug-induced sleep endoscopy, up to 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
Kevin Motz, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Johns Hopkins 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 1 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin M Motz (410614245, kmotz1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal airflow with direct genioglossus stimulation (time frame: at the time of drug-induced sleep endoscopy, up to 1 hour). The study lists 2 primary outcomes in all. 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 24 Dec 2025.