Obstructive Sleep ApneaNCT04457154
Pediatric Post-Approval Registry
An observational study of Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 8 sites in United States.
Trial summary
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant. Read more about this study
- Who is it for?
- Ages 18 to 21 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Inspire Upper Airway Stimulation System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Nov 2021to Apr 2028
- How long will I take part?
- 5 Years
- 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 to 21 years
- All sexes
- No healthy volunteers
- Adult
Study population: Pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA).
Who may be able to join
- Subject is between 18 and 21 years of age;
- Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
- Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
- Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Subject has followed standard of care in considering all other alternative/adjunct therapies;
- Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
- Subject is willing and able to provide informed consent.
Who cannot join
- Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
- Subject 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;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable, or does not have the necessary assistance, to operate the patient remote;
- Subject is pregnant or plans to become pregnant;
- Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
- Subject has a terminal illness with life expectancy < 12 months;
- Any other reason the investigator deems the subject is unfit for participation in the registry.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mike Swierzewski, MS contact
8 sites in 1 country
United States8 sites, 7 recruiting
- Terminated
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
- Recruiting
Childrens Hospital of Colorado
Aurora, Colorado, 80045
Kari Gorecki, kari.gorecki@cuanschutz.edu
Norman Friedman, MD
- Recruiting
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229
Angie Duggins, angie.duggins@cchmc.org
David Smith, MD
- Recruiting
University of Texas Southwestern/Children's Hospital of Dallas
Dallas, Texas, 75207
Francesca Chambers, Francesca.Chambers@UTSouthwestern.edu
Ron Mitchell, MD
- Recruiting
Duke University
Durham, North Carolina, 27705
Donald Luckett, donald.luckett@duke.edu
Eileen Raynor, MD
- Recruiting
Children's Hospital of the King's Daughters/East Virginia Medical School
Norfolk, Virginia, 23507
Lakshya Enugu, enugul@evms.edu
Cristina Baldassari, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19406
Ashley Williams, williamsab@chop.edu
Lisa Elden, MD
- Recruiting
Children's Hospital of Pittsburgh
Sewickley, Pennsylvania, 15143
Amber Shaffer, shafferad@upmc.edu
Rachel Whelan, MD
About this study
Official title: Inspire Pediatric Post-Approval Registry
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Read the detailed description
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.
This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States.
Study data will be collected at the following timepoints:
Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant
1, 2, 3, 4, 5 years post-implant
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Inspire Upper Airway Stimulation System
- Keywords
- Pediatric, Apnea-hypopnea Index, Sleep Breathing Disorders
- 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 Upper Airway Stimulation SystemDevice
Implant of the Inspire Upper Airway Stimulation System
| Study group | Role | What they receive |
|---|---|---|
| Registry Population | Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA) Receives: Device: Inspire Upper Airway Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of device and/or procedure related adverse events over time
relevant adverse events will be collected and reported
Measured: Implant through 5 years post-implant
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.
Measured: through 5 years post-implant
Secondary outcomes (3)
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time
Baseline (pre-implant) Oxygen Desaturation Index (ODI) compared to ODI after implant (collected and reported at annual study visits). The Oxygen Desaturation Index (ODI) is the number of oxygen desaturations, with at least a 4% drop from baseline, per hour. A lower ODI indicates less severe sleep apnea.
Measured: through 5 years post-implant
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time
Baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits). T90 is defined as the total sleep time spent with arterial oxygen saturation (SaO2) < 90%. A lower T90 indicates less severe sleep apnea.
Measured: through 5 years post-implant
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time
Baseline (pre-implant) Epworth Sleepiness Scale (ESS) compared to ESS after implant (collected and reported at annual study visits). The Epworth Sleepiness Scale is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations. Scores range from 0 to 24, with a lower score indicating less daytime sleepiness. An ESS score of 10 or less is equivalent to the normalized population.
Measured: 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 posted7 Jul 2020
- Study start30 Nov 2021
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
- Target duration
- 5 Years
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
- NCT04457154
- Sponsor's protocol ID
- 2020-002
- Status last verified
- Aug 2024
- First submitted
- 30 Jun 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspire Pediatric Post-Approval Registry
- ClinicalTrials.gov ID
- NCT04457154
- Acronym / sponsor ID
- 2020-002
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Pediatric, Apnea-hypopnea Index, Sleep Breathing Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 7 Jul 2020 (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 registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Detailed description
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures.
This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States.
Study data will be collected at the following timepoints:
Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant
1, 2, 3, 4, 5 years post-implant
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry Population | – | Device: Inspire Upper Airway Stimulation SystemPediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA) |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA).
Key inclusion criteria (8 listed)
- Subject is between 18 and 21 years of age;
- Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
- Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
- Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Subject has followed standard of care in considering all other alternative/adjunct therapies;
Key exclusion criteria (8 listed)
- Subject has a combination of central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
- Subject 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;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable, or does not have the necessary assistance, to operate the patient remote;
- Subject 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 |
|---|---|---|
| Inspire Upper Airway Stimulation SystemImplant of the Inspire Upper Airway Stimulation System | Device | Registry Population |
Primary outcome
Evaluation of device and/or procedure related adverse events over time
Time frame: Implant through 5 years post-implant
relevant adverse events will be collected and reported
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
Time frame: through 5 years post-implant
Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.
3 secondary outcomes
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time
Time frame: through 5 years post-implant
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time
Time frame: through 5 years post-implant
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time
Time frame: 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 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mike Swierzewski, MS contact
8 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, run by Inspire Medical Systems, Inc. at 8 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 8 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: looking for participants now, as of the sponsor's last update on 25 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 8 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 Gwen Gimmestad (763-392-9966, gwengimmestad@inspiresleep.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of device and/or procedure related adverse events over time (time frame: Implant through 5 years post-implant). 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 25 Feb 2025.