Obstructive Sleep ApneaNCT07898618
Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea With Complete Concentric Collapse
A study testing Inspire Hypoglossal Nerve Stimulation System in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
This study examines how hypoglossal nerve stimulation affects breathing and sleep apnea in adults whose airway closes from all sides at the soft palate during sleep, a pattern called complete concentric collapse. 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?
- Inspire Hypoglossal Nerve Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 1 Jun 2031
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) ≥15 events/hour, confirmed by attended in-laboratory polysomnography (PSG) before enrollment and implantation.
- Complete concentric collapse (CCC) of the soft palate on clinically obtained drug-induced sleep endoscopy (DISE).
- Otherwise considered an appropriate candidate for HGNS implantation by the treating surgical and sleep medicine team, aside from CCC status.
- Prior CPAP failure or intolerance, consistent with usual HGNS candidacy evaluation.
- Ability to provide informed consent.
- Willingness to undergo investigational HGNS implantation and required follow-up procedures under the research protocol.
Who cannot join
- Contraindications to HGNS implantation or conditions that, in the judgment of the treating clinicians or investigators, make investigational HGNS use unsafe or inappropriate.
- Central or mixed sleep apnea comprising >25% of total respiratory events.
- Any unstable or uncontrolled medical condition that, in the judgment of the investigator, would increase procedural risk or interfere with study participation.
- Inability to safely undergo study procedures, including overnight sleep studies or physiological monitoring.
- Prior HGNS implantation.
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Physiological and Anatomical Determinants of Hypoglossal Nerve Stimulation Outcomes in Complete Concentric Collapse Investigational Cohort
This study examines how hypoglossal nerve stimulation affects breathing and sleep apnea in adults whose airway closes from all sides at the soft palate during sleep, a pattern called complete concentric collapse. Participants will receive an Inspire hypoglossal nerve stimulation implant and undergo sleep studies, questionnaires, and home monitoring. This use of the device is investigational. The study will measure changes in airway collapsibility, sleep apnea severity, device use, and safety through 12 months after implantation.
Read the detailed description
This prospective, single-center, open-label investigational cohort will enroll up to 20 adults with obstructive sleep apnea and complete concentric collapse of the soft palate on clinically obtained drug-induced sleep endoscopy. Research assessments occur at Brigham and Women's Hospital; implantation occurs at Massachusetts Eye and Ear. Investigational implantation is conducted under FDA IDE G260193. All enrolled participants receive the intervention; there is no randomization or separate treatment comparison arm.
Baseline eligibility requires attended laboratory polysomnography before implantation. A suitable recent clinical polysomnogram may be used; otherwise a research polysomnogram is obtained after consent. Activation is approximately four weeks after implantation and titration approximately three months after implantation. HGNS-on sleep testing and questionnaires occur approximately one month after titration, targeting completion by six months after implantation, and again at 12 months. Follow-up testing may use laboratory polysomnography or the Nox A1 home sleep testing system.
At 4-12 months after implantation, once device settings are stable, participants undergo a dedicated physiological sleep study following four nights without HGNS. Critical closing pressure is measured during brief CPAP pressure drops with HGNS off and on. During the second portion of the night, HGNS is off and airflow and intraesophageal diaphragm electromyography are used to characterize physiological traits. Participants also complete seven days of wearable ring monitoring; device downloads at the first in-laboratory visit 4-12 months after implantation quantify adherence.
The CCC cohort provides within-participant physiological and clinical response estimates. Prespecified pooled analyses combine these data with a separately enrolled standard-of-care non-CCC cohort. The primary pooled mechanistic comparison evaluates HGNS-induced changes in critical closing pressure between lateral collapse (CCC or complete oropharyngeal lateral wall collapse) and predominantly anteroposterior collapse. Companion-study participants are not included in this registration's enrollment. Exploratory analyses assess physiological traits, treatment response, adherence, and prediction of clinical success.
An independent Data and Safety Monitoring Board reviews safety and treatment response. New enrollment and implantation pause after the first ten implants pending the required response checkpoints and DSMB review. Safety follow-up continues through 12 months after implantation, with continued follow-up of unresolved events as needed.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Inspire Hypoglossal Nerve Stimulation System
- Keywords
- Hypoglossal nerve stimulation, Complete concentric collapse, Pharyngeal collapsibility
- 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.
Inspire Hypoglossal Nerve Stimulation SystemDevice
Also called Inspire Upper Airway Stimulation
Implanted hypoglossal nerve stimulation for obstructive sleep apnea in participants with complete concentric collapse. The system is activated approximately four weeks after implantation and titrated approximately three months after implantation. Stimulation is briefly turned on and off during physiological measurements. Participants withhold HGNS for four nights before the physiological sleep study and resume usual treatment after testing.
| Study group | Role | What they receive |
|---|---|---|
| Investigational HGNS in CCC | Experimental | Adults with complete concentric collapse receive Inspire HGNS implantation, activation, titration, and follow-up, with physiological testing and safety assessments through 12 months after implantation. Receives: Device: Inspire Hypoglossal Nerve Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
HGNS-induced change in pharyngeal critical closing pressure (Pcrit)
Difference in critical closing pressure (cm H2O), calculated as Pcrit with HGNS off minus Pcrit with HGNS on during the same physiological study. Larger positive values indicate greater improvement. Pcrit is measured using brief CPAP pressure drops. CCC-specific results will be characterized, and CCC data will contribute to the prespecified pooled comparison of lateral versus predominantly anteroposterior collapse using a separately enrolled companion cohort.
Measured: During one overnight physiological study 4-12 months after implantation, once HGNS settings are stable
Secondary outcomes (12)
Percentage reduction in apnea-hypopnea index (AHI)
Percentage reduction from the participant's own pre-implant baseline AHI to HGNS-on follow-up AHI: 100 × (baseline AHI minus treated AHI) / baseline AHI. AHI is the number of apneas and hypopneas per hour of sleep. Larger positive percentages indicate greater improvement.
Measured: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Percentage of participants meeting HGNS treatment-response criteria
Response is defined as at least a 50% reduction in AHI from pre-implant baseline and a treated AHI below 15 events/hour.
Measured: Approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
HGNS use relative to total sleep time
Average nightly HGNS use over the preceding month divided by average nightly total sleep time estimated from seven nights of wearable ring monitoring. HGNS use is obtained from the device download at the first in-laboratory study visit 4-12 months after implantation.
Measured: Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation
Percentage of participants meeting HGNS adherence criteria
Adherence is defined as device use for at least 4 hours per night on at least 70% of nights, based on device downloads.
Measured: Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation
Epworth Sleepiness Scale
The Epworth Sleepiness Scale assesses subjective daytime sleepiness. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation.
Measured: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Sleep Disturbance Short Form 8b
The PROMIS Sleep Disturbance Short Form 8b assesses perceptions of sleep quality, sleep depth, and difficulties with sleep. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater sleep disturbance (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation.
Measured: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Sleep-Related Impairment Short Form 8a
The PROMIS Sleep-Related Impairment Short Form 8a assesses daytime impairment associated with poor sleep, including sleepiness, fatigue, and reduced alertness. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater sleep-related impairment (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation.
Measured: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Sleep Apnea Quality of Life Index - Short Form
The Sleep Apnea Quality of Life Index (SAQLI) assesses disease-specific quality of life in obstructive sleep apnea. Total scores range from 1 to 7, with higher scores indicating better sleep-related quality of life (better outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation.
Measured: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Fatigue Short Form 7a
The PROMIS Fatigue Short Form 7a assesses the experience and impact of fatigue on daily functioning. Scores are reported as standardized T-scores (mean = 50 and SD = 10), with higher scores indicating greater fatigue (worse outcome). Assessed at baseline, the early post-titration visit, and 12 months after implantation.
Measured: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Snoring severity visual analog scale
Participants rate snoring severity on a 0-10 visual analog scale, where 0 indicates no snoring and 10 indicates extremely loud, frequent, and bothersome snoring. Higher scores indicate worse snoring. Assessed at baseline, the early post-titration visit, and 12 months after implantation.
Measured: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Treatment satisfaction visual analog scale
Participants rate satisfaction with their sleep apnea treatment on a 0-10 visual analog scale, where 0 indicates extremely dissatisfied, 5 indicates neutral / no benefit, and 10 indicates extremely satisfied. Higher scores indicate greater treatment satisfaction. Assessed at the early post-titration visit and 12 months after implantation.
Measured: Approximately 1 month after titration and 12 months after implantation
Number of participants with device-related adverse events or surgical complications
Participants with device-related adverse events or surgical complications, including explantation or revision and stimulation intolerance requiring discontinuation or major programming changes. Inadequate therapeutic response requiring reassessment is also monitored. Unresolved events are followed beyond 12 months when needed.
Measured: From implantation through 12 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective open-label investigational CCC cohort. All participants receive HGNS implantation. HGNS-on/off physiological measurements are obtained within participants; non-CCC participants are enrolled under a separate protocol.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Inspire Medical Systems, Inc., Massachusetts Eye and Ear Infirmary
- Responsible party
- Principal investigator, Daniel Vena, PhD, Brigham and Women's Hospital
- Investigators
- Daniel Vena, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898618
- Sponsor's protocol ID
- 2026P002777
- Other IDs
- 1R01HL180582
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data underlying published results may be shared with qualified researchers for scientific collaboration. These may include participant characteristics, sleep study outcomes, physiological measurements, HGNS usage, and questionnaire scores. Requests will be reviewed by the Principal Investigator for scientific merit and consistency with participant consent and institutional requirements. Sharing will be subject to any required data use agreement.
Publications
Huyett P, Kent DT, D'Agostino MA, Green KK, Soose RJ, Kaffenberger TM, Woodson BT, Huntley C, Boon MS, Heiser C, Birk A, Suurna MV, Lin HS, Waxman JA, Kezirian EJ. Drug-Induced Sleep Endoscopy and Hypoglossal Nerve Stimulation Outcomes: A Multicenter Cohort Study. Laryngoscope. 2021 Jul;131(7):1676-1682. doi: 10.1002/lary.29396. Epub 2021 Jan 14.
PubMed 33443811Vena D, Kezirian EJ, Wellman A, Kent D, D'Agostino M, Monteiro JLGC, Azarbarzin A, Chen T, Sands SA, Huyett P. Association between body mass index and unilateral hypoglossal nerve stimulation efficacy depends on the pattern of pharyngeal collapse in obstructive sleep apnea. Am J Respir Crit Care Med. 2026 Aug 10:aamag427. doi: 10.1093/ajrccm/aamag427. Online ahead of print. No abstract available.
PubMed 42576311Vena D, Op de Beeck S, Yang H, Sumner J, Mann D, Wang TY, Aishah A, Azarbarzin A, Messineo L, Calianese N, Alex R, Esmaeili N, Vanderveken OM, White DP, Wellman A, Huyett P, Sands SA. Lateral wall collapse from sleep endoscopy and airflow shape predicts hypoglossal nerve stimulation efficacy in obstructive sleep apnoea. Eur Respir J. 2025 Oct 7;66(4):2500236. doi: 10.1183/13993003.00236-2025. Print 2025 Oct.
PubMed 40774807Vanderveken OM, Maurer JT, Hohenhorst W, Hamans E, Lin HS, Vroegop AV, Anders C, de Vries N, Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med. 2013 May 15;9(5):433-8. doi: 10.5664/jcsm.2658.
PubMed 23674933
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Anatomical Determinants of Hypoglossal Nerve Stimulation Outcomes in Complete Concentric Collapse Investigational Cohort
- ClinicalTrials.gov ID
- NCT07898618
- Acronym / sponsor ID
- 2026P002777
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Hypoglossal nerve stimulation, Complete concentric collapse, Pharyngeal collapsibility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Inspire Medical Systems, Inc., Massachusetts Eye and Ear Infirmary
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 27 Oct 2026 (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.
This study examines how hypoglossal nerve stimulation affects breathing and sleep apnea in adults whose airway closes from all sides at the soft palate during sleep, a pattern called complete concentric collapse. Participants will receive an Inspire hypoglossal nerve stimulation implant and undergo sleep studies, questionnaires, and home monitoring. This use of the device is investigational. The study will measure changes in airway collapsibility, sleep apnea severity, device use, and safety through 12 months after implantation.
Detailed description
This prospective, single-center, open-label investigational cohort will enroll up to 20 adults with obstructive sleep apnea and complete concentric collapse of the soft palate on clinically obtained drug-induced sleep endoscopy. Research assessments occur at Brigham and Women's Hospital; implantation occurs at Massachusetts Eye and Ear. Investigational implantation is conducted under FDA IDE G260193. All enrolled participants receive the intervention; there is no randomization or separate treatment comparison arm.
Baseline eligibility requires attended laboratory polysomnography before implantation. A suitable recent clinical polysomnogram may be used; otherwise a research polysomnogram is obtained after consent. Activation is approximately four weeks after implantation and titration approximately three months after implantation. HGNS-on sleep testing and questionnaires occur approximately one month after titration, targeting completion by six months after implantation, and again at 12 months. Follow-up testing may use laboratory polysomnography or the Nox A1 home sleep testing system.
At 4-12 months after implantation, once device settings are stable, participants undergo a dedicated physiological sleep study following four nights without HGNS. Critical closing pressure is measured during brief CPAP pressure drops with HGNS off and on. During the second portion of the night, HGNS is off and airflow and intraesophageal diaphragm electromyography are used to characterize physiological traits. Participants also complete seven days of wearable ring monitoring; device downloads at the first in-laboratory visit 4-12 months after implantation quantify adherence.
The CCC cohort provides within-participant physiological and clinical response estimates. Prespecified pooled analyses combine these data with a separately enrolled standard-of-care non-CCC cohort. The primary pooled mechanistic comparison evaluates HGNS-induced changes in critical closing pressure between lateral collapse (CCC or complete oropharyngeal lateral wall collapse) and predominantly anteroposterior collapse. Companion-study participants are not included in this registration's enrollment. Exploratory analyses assess physiological traits, treatment response, adherence, and prediction of clinical success.
An independent Data and Safety Monitoring Board reviews safety and treatment response. New enrollment and implantation pause after the first ten implants pending the required response checkpoints and DSMB review. Safety follow-up continues through 12 months after implantation, with continued follow-up of unresolved events as needed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective open-label investigational CCC cohort. All participants receive HGNS implantation. HGNS-on/off physiological measurements are obtained within participants; non-CCC participants are enrolled under a separate protocol.
| Arm | Type | Receives |
|---|---|---|
| Investigational HGNS in CCC | Experimental | Device: Inspire Hypoglossal Nerve Stimulation SystemAdults with complete concentric collapse receive Inspire HGNS implantation, activation, titration, and follow-up, with physiological testing and safety assessments through 12 months after implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) ≥15 events/hour, confirmed by attended in-laboratory polysomnography (PSG) before enrollment and implantation.
- Complete concentric collapse (CCC) of the soft palate on clinically obtained drug-induced sleep endoscopy (DISE).
- Otherwise considered an appropriate candidate for HGNS implantation by the treating surgical and sleep medicine team, aside from CCC status.
- Prior CPAP failure or intolerance, consistent with usual HGNS candidacy evaluation.
Key exclusion criteria (6 listed)
- Contraindications to HGNS implantation or conditions that, in the judgment of the treating clinicians or investigators, make investigational HGNS use unsafe or inappropriate.
- Central or mixed sleep apnea comprising >25% of total respiratory events.
- Any unstable or uncontrolled medical condition that, in the judgment of the investigator, would increase procedural risk or interfere with study participation.
- Inability to safely undergo study procedures, including overnight sleep studies or physiological monitoring.
- Prior HGNS implantation.
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 |
|---|---|---|
| Inspire Hypoglossal Nerve Stimulation SystemAlso: Inspire Upper Airway StimulationImplanted hypoglossal nerve stimulation for obstructive sleep apnea in participants with complete concentric collapse. The system is activated approximately four weeks after implantation and titrated approximately three months after implantation. Stimulation is briefly turned on and off during physiological measurements. Participants withhold HGNS for four nights before the physiological sleep study and resume usual treatment after testing. | Device | Investigational HGNS in CCC |
Primary outcome
HGNS-induced change in pharyngeal critical closing pressure (Pcrit)
Time frame: During one overnight physiological study 4-12 months after implantation, once HGNS settings are stable
Difference in critical closing pressure (cm H2O), calculated as Pcrit with HGNS off minus Pcrit with HGNS on during the same physiological study. Larger positive values indicate greater improvement. Pcrit is measured using brief CPAP pressure drops. CCC-specific results will be characterized, and CCC data will contribute to the prespecified pooled comparison of lateral versus predominantly anteroposterior collapse using a separately enrolled companion cohort.
12 secondary outcomes
Percentage reduction in apnea-hypopnea index (AHI)
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Percentage of participants meeting HGNS treatment-response criteria
Time frame: Approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
HGNS use relative to total sleep time
Time frame: Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation
Percentage of participants meeting HGNS adherence criteria
Time frame: Prior month of device use, downloaded at the first in-laboratory study visit 4-12 months after implantation
Epworth Sleepiness Scale
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Sleep Disturbance Short Form 8b
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Sleep-Related Impairment Short Form 8a
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Sleep Apnea Quality of Life Index - Short Form
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
PROMIS Fatigue Short Form 7a
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Snoring severity visual analog scale
Time frame: Pre-implant baseline, approximately 1 month after titration (target by 6 months after implantation), and 12 months after implantation
Treatment satisfaction visual analog scale
Time frame: Approximately 1 month after titration and 12 months after implantation
Number of participants with device-related adverse events or surgical complications
Time frame: From implantation through 12 months after implantation
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 27 Oct 2026.
- Background: PubMed 33443811Huyett P, Kent DT, D'Agostino MA, Green KK, Soose RJ, Kaffenberger TM, Woodson BT, Huntley C, Boon MS, Heiser C, Birk A, Suurna MV, Lin HS, Waxman JA, Kezirian EJ. Drug-Induced Sleep Endoscopy and Hypoglossal Nerve Stimulation Outcomes: A Multicenter Cohort Study. Laryngoscope. 2021 Jul;131(7):1676-1682. doi: 10.1002/lary.29396. Epub 2021 Jan 14.
- Background: PubMed 42576311Vena D, Kezirian EJ, Wellman A, Kent D, D'Agostino M, Monteiro JLGC, Azarbarzin A, Chen T, Sands SA, Huyett P. Association between body mass index and unilateral hypoglossal nerve stimulation efficacy depends on the pattern of pharyngeal collapse in obstructive sleep apnea. Am J Respir Crit Care Med. 2026 Aug 10:aamag427. doi: 10.1093/ajrccm/aamag427. Online ahead of print. No abstract available.
- Background: PubMed 40774807Vena D, Op de Beeck S, Yang H, Sumner J, Mann D, Wang TY, Aishah A, Azarbarzin A, Messineo L, Calianese N, Alex R, Esmaeili N, Vanderveken OM, White DP, Wellman A, Huyett P, Sands SA. Lateral wall collapse from sleep endoscopy and airflow shape predicts hypoglossal nerve stimulation efficacy in obstructive sleep apnoea. Eur Respir J. 2025 Oct 7;66(4):2500236. doi: 10.1183/13993003.00236-2025. Print 2025 Oct.
- Background: PubMed 23674933Vanderveken OM, Maurer JT, Hohenhorst W, Hamans E, Lin HS, Vroegop AV, Anders C, de Vries N, Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med. 2013 May 15;9(5):433-8. doi: 10.5664/jcsm.2658.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published results may be shared with qualified researchers for scientific collaboration. These may include participant characteristics, sleep study outcomes, physiological measurements, HGNS usage, and questionnaire scores. Requests will be reviewed by the Principal Investigator for scientific merit and consistency with participant consent and institutional requirements. Sharing will be subject to any required data use agreement.
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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.
Daniel Vena, PhD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspire Hypoglossal Nerve Stimulation System in people with Obstructive Sleep Apnea, run by Brigham and Women's Hospital at 2 sites 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 6 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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 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 Daniel Vena, PhD (617-852-0719, dvena@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HGNS-induced change in pharyngeal critical closing pressure (Pcrit) (time frame: During one overnight physiological study 4-12 months after implantation, once HGNS settings are stable). 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 NCT07898618, which also lists 4 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 27 Oct 2026.