Obstructive Sleep ApneaNCT02413970
Inspire® Post-Approval Study / Protocol Number 2014-001
A study testing Inspire® UAS System in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Inspire® UAS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 14 sitesUnited States
- Study dates
- May 2015to Jun 2025
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (AHI >= 15) based on a prior sleep study
- Documentation the subject not effectively treated with CPAP therapy. (Examples include non-compliance, discomfort, undesirable side effects, symptoms persist despite use). Subjects who have been prescribed, but refuse to try CPAP would be considered intolerant.
- Age 22 or above
- Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
- Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
- Willing and capable of providing informed consent
Who cannot join
- Contraindications:
- Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- Any condition or procedure that has compromised neurological control of the upper airway
- Patients who are unable or do not have the necessary assistance to operate the patient remote
- Patients who are pregnant or plan to become pregnant
Show all 13Show fewer
- Patients who will require magnetic resonance imaging (MRI)
- Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system.
- Additional exclusions for study purposes only:
- Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
- Has a terminal illness with life expectancy < 12 months
- Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
- Any other reason the investigator deems subject is unfit for participation in the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
The University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
The Christ Hospital
Cincinnati, Ohio, 45219
University Hospitals
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California
Los Angeles, California, 90033
Kentucky Research Group
Louisville, Kentucky, 40218
South Miami Hospital
Miami, Florida, 33183
Weill Cornell Medicine
New York, New York, 10021
University of Pennsylvania, Division of Sleep Medicine
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University and Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
Read the detailed description
This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant.
Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.
This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected.
Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 \& 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, \& 5 year follow-up visits.
The subject population will consist of otherwise healthy men and women that are at least 22 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol.
Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Inspire® UAS System
- Keywords
- OSA, Neurostimulation, Hypoglossal nerve, Tongue, Upper airway stimulation, Surgery
- 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® UAS SystemDevice
Also called Inspire® therapy
This is a single-arm study; all participants will be implanted with the Inspire® UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.
| Study group | Role | What they receive |
|---|---|---|
| Inspire® UAS System | Other | This is a single-arm study; all participants will be implanted with the Inspire® UAS System. Receives: Device: Inspire® UAS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Device-Related SAEs
This safety endpoint is to assess long-term (5 years) safety via comparison of device-related SAEs with a performance goal of 24%. The objective at 5 years is to demonstrate the device-related SAE rate is no worse than the performance goal.
Measured: 5 Years Post-Implant
Therapy Specific AEs
This safety endpoint is to evaluate the safety of the Inspire system in the treatment of sleep apnea by evaluating procedure- and device-related AEs occurring immediately post-implant through 12 months post-implant.
Measured: 12 Months Post-Implant
Long-term Therapy-Related AEs
This safety endpoint is to assess long-term (5 years) safety via the description of all reported AEs, including all therapy- and procedure-related events.
Measured: 5 Years Post-Implant
Secondary outcomes (1)
Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
This endpoint is to assess the performance of newly trained physicians, the post-approval study will collect surgical times, post-operative pain recovery, procedure related AEs, and post-operative comments.
Measured: 30 days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Inspire UAS
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gwen Gimmestad, Study director, Inspire Medical Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413970
- Sponsor's protocol ID
- 2014-001
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2015
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001
- ClinicalTrials.gov ID
- NCT02413970
- Acronym / sponsor ID
- 2014-001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Neurostimulation, Hypoglossal nerve, Tongue, Upper airway stimulation, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Apr 2015 (estimated)
- 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 study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.
Detailed description
This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant.
Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.
This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected.
Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 \& 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, \& 5 year follow-up visits.
The subject population will consist of otherwise healthy men and women that are at least 22 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol.
Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inspire UAS
| Arm | Type | Receives |
|---|---|---|
| Inspire® UAS System | Other | Device: Inspire® UAS SystemThis is a single-arm study; all participants will be implanted with the Inspire® UAS System. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Likely suffer moderate-to-severe OSA based on history and physical or have an established diagnosis of OSA (AHI >= 15) based on a prior sleep study
- Documentation the subject not effectively treated with CPAP therapy. (Examples include non-compliance, discomfort, undesirable side effects, symptoms persist despite use). Subjects who have been prescribed, but refuse to try CPAP would be considered intolerant.
- Age 22 or above
- Willing and capable to have stimulation hardware permanently implanted, and to use the patient remote to activate the stimulation
- Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
Key exclusion criteria (13 listed)
- Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
- Any condition or procedure that has compromised neurological control of the upper airway
- Patients who are unable or do not have the necessary assistance to operate the patient remote
- Patients who are pregnant or plan 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® UAS SystemAlso: Inspire® therapyThis is a single-arm study; all participants will be implanted with the Inspire® UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy. | Device | Inspire® UAS System |
Primary outcome
Long-term Device-Related SAEs
Time frame: 5 Years Post-Implant
This safety endpoint is to assess long-term (5 years) safety via comparison of device-related SAEs with a performance goal of 24%. The objective at 5 years is to demonstrate the device-related SAE rate is no worse than the performance goal.
Therapy Specific AEs
Time frame: 12 Months Post-Implant
This safety endpoint is to evaluate the safety of the Inspire system in the treatment of sleep apnea by evaluating procedure- and device-related AEs occurring immediately post-implant through 12 months post-implant.
Long-term Therapy-Related AEs
Time frame: 5 Years Post-Implant
This safety endpoint is to assess long-term (5 years) safety via the description of all reported AEs, including all therapy- and procedure-related events.
1 secondary outcome
Number of Acute AEs Reported with Newly Trained Physicians as Compared to Experienced Physicians
Time frame: 30 days post-implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
Gwen Gimmestad study director
Inspire Medical Systems, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspire® UAS System in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 14 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
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?
Long-term Device-Related SAEs (time frame: 5 Years Post-Implant). The study lists 3 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 27 Dec 2024.