Pediatric Obstructive Sleep ApneaNCT06851338
Pediatric Down Syndrome Post-Approval Study
A study testing Hypoglossal Nerve Stimulation in people with Pediatric Obstructive Sleep Apnea and Down Syndrome (DS), run by Inspire Medical Systems, Inc. at 6 sites in United States.
Trial summary
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Pediatric Obstructive Sleep Apnea, Down Syndrome (DS)
- What is being tested?
- Hypoglossal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2025to May 2030
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient has been diagnosed with Down syndrome;
- Patient is 13-18 years of age;
- Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
- Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
- Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Treatment of patient's OSA has followed standard of care in considering all other alternative/adjunctive therapies;
- Patient, and their parents/guardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.
Who cannot join
- Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
- Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
- Patient has any condition or procedure that has compromised neurological control of the upper airway;
- Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
- Patient is pregnant or plans to become pregnant;
- Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;
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- Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
- Patient has a terminal illness with life expectancy of less than 12 months;
- Any other reason the investigator deems the patient is unfit for participation in the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Alex Piczer, PICZERA@ccf.org
Vaishal Shah, MD
- Recruiting
Baylor College of Medicine/ Texas Children's Hospital
Houston, Texas, 77030
Sadaf Batla, sxbatla@texaschildrens.org
Mary F Musso, MD
- Not yet recruiting
Children's Hospital Orange County
Orange, California, 92868
Eric Rodriguez, Eric.Rodriguez@choc.org
Chana Chin, MD
- Not yet recruiting
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Chase Beckerman, cbeckerman@phoenixchildrens.com
Richard Law, MD
- Not yet recruiting
Northwell Cohen Children's Hospital
Queens, New York, 11040
Virginia Mullooly, GMullool@northwell.edu
Patrick Scheffler, MD
- Not yet recruiting
University of South Florida Morsani College of Medicine
Tampa, Florida, 33602
Alex Czachor, aczachor@tgh.org
Abhay Sharma, MD
About this study
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.
Read the detailed description
This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow sixty (60) adolescents (13 - 18), with Down Syndrome and severe sleep apnea for 5-years after undergoing implant of the Inspire Upper Airway Stimulation (UAS) system. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatrics Down Syndrome population.
Prior to implant subjects will be required to meet eligibility criteria that is based on an in-lab PSG, surgical consultation and drug induced sleep endoscopy, as well as other assessments. Subjects will also complete quality of life questionnaires.
During the 5-year follow-up period, data will be collected at the time of implant, and at multiple follow-up visits through five years post-implant. At each of these visits, safety information (adverse events), sleep data, therapy usage, and quality of life will be collected.
A total of sixty (60) subjects with even distribution across the age range will be implanted at a minimum of five (5) clinical centers in the US.
Subjects will conclude their participation in the study at the end of their 5 year follow-up visit.
- Being tested
- Hypoglossal Nerve Stimulation
- Keywords
- Pediatrics, OSA, Down Syndrome, Pediatrics OSA, Obstructive Sleep Apnea, Long-term follow-up, Post Approval Study, PAS
- Medical subject headings
- Down Syndrome, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglossal Nerve StimulationDevice
Also called Inspire Upper Airway Stimulation (UAS) System
Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population
| Study group | Role | What they receive |
|---|---|---|
| Pediatric subjects with Down syndrome undergoing Inspire UAS Implant | Experimental | This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA). Receives: Device: Hypoglossal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome Measure - Procedure and Device-related Adverse events
Procedure-related and Device-related adverse events will be summarized by seriousness and severity. No formal hypothesis will be tested.
Measured: Implant through 5 Years
Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI)
The AHI will be collected at each sleep study. This effectiveness measure will be reported as a comparison of baseline and annual (1-5 year) AHI.
Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Measured: Baseline and Annually through 5 Years post-implant
Secondary outcomes (3)
Effectiveness Outcome Measure - Comparison of Baseline, 6 month, and Annual Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
The ESS-CHAD will be completed at baseline, as well as 6 months and annually (1-5 years) post-implant. The ESS-CHAD score at baseline compared to the ESS-CHAD score at each annual study visit will be reported.
Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Measured: Baseline, 6 months, and annually through 5-year post-implant
Effectiveness Outcome Measure - Comparison of Baseline and Annual Percent Time Oxygen Saturation < 90% (T90)
Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Measured: Baseline and Annually through 5-year post-implant
Effectiveness Outcome Measure - Comparison of Baseline and Annual Oxygen Desaturation Index (ODI)
The ODI will be collected during each sleep study. This effectiveness measure will be reported as a comparison of baseline and annual (1-5 year) ODI.
Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
Measured: Baseline and Annually through 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851338
- Sponsor's protocol ID
- 2023-002
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Down Syndrome Post-Approval Study
- ClinicalTrials.gov ID
- NCT06851338
- Acronym / sponsor ID
- 2023-002
- Keywords
- Pediatrics, OSA, Down Syndrome, Pediatrics OSA, Obstructive Sleep Apnea, Long-term follow-up, Post Approval Study, PAS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 28 Feb 2025 (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 Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.
Detailed description
This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow sixty (60) adolescents (13 - 18), with Down Syndrome and severe sleep apnea for 5-years after undergoing implant of the Inspire Upper Airway Stimulation (UAS) system. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatrics Down Syndrome population.
Prior to implant subjects will be required to meet eligibility criteria that is based on an in-lab PSG, surgical consultation and drug induced sleep endoscopy, as well as other assessments. Subjects will also complete quality of life questionnaires.
During the 5-year follow-up period, data will be collected at the time of implant, and at multiple follow-up visits through five years post-implant. At each of these visits, safety information (adverse events), sleep data, therapy usage, and quality of life will be collected.
A total of sixty (60) subjects with even distribution across the age range will be implanted at a minimum of five (5) clinical centers in the US.
Subjects will conclude their participation in the study at the end of their 5 year follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric subjects with Down syndrome undergoing Inspire UAS Implant | Experimental | Device: Hypoglossal Nerve StimulationThis study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patient has been diagnosed with Down syndrome;
- Patient is 13-18 years of age;
- Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
- Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
- Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;
Key exclusion criteria (9 listed)
- Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
- Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
- Patient has any condition or procedure that has compromised neurological control of the upper airway;
- Patient, or their parent/guardian, is unable or does not have the necessary assistance to operate the patient remote;
- Patient is pregnant or plans to become pregnant;
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 StimulationAlso: Inspire Upper Airway Stimulation (UAS) SystemImplant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population | Device | Pediatric subjects with Down syndrome undergoing Inspire UAS Implant |
Primary outcome
Safety Outcome Measure - Procedure and Device-related Adverse events
Time frame: Implant through 5 Years
Procedure-related and Device-related adverse events will be summarized by seriousness and severity. No formal hypothesis will be tested.
Effectiveness Outcome Measure - Comparison of Baseline and Annual Apnea-Hypopnea Index (AHI)
Time frame: Baseline and Annually through 5 Years post-implant
The AHI will be collected at each sleep study. This effectiveness measure will be reported as a comparison of baseline and annual (1-5 year) AHI. Descriptive statistics will be used to analyze this data. No formal hypothesis will be tested.
3 secondary outcomes
Effectiveness Outcome Measure - Comparison of Baseline, 6 month, and Annual Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
Time frame: Baseline, 6 months, and annually through 5-year post-implant
Effectiveness Outcome Measure - Comparison of Baseline and Annual Percent Time Oxygen Saturation < 90% (T90)
Time frame: Baseline and Annually through 5-year post-implant
Effectiveness Outcome Measure - Comparison of Baseline and Annual Oxygen Desaturation Index (ODI)
Time frame: Baseline and Annually through 5 years post-implant
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 28 Feb 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.
6 sites 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 in people with Pediatric Obstructive Sleep Apnea and Down Syndrome (DS), run by Inspire Medical Systems, Inc. at 6 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 9 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Angela Chapin, Sr. Clinical Study Manager (763.392.7222, angelachapin@inspiresleep.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome Measure - Procedure and Device-related Adverse events (time frame: Implant through 5 Years). 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 28 Feb 2025.