Obstructive Sleep ApneaPhase 4RCTNCT02675816
Inspire® Upper Airway Stimulation System
A Phase 4 study testing Inspire® Upper Airway Stimulation (UAS) System in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 4 sites in 2 countries.
Trial summary
The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Inspire® Upper Airway Stimulation (UAS) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2015to Jul 2016
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet the requirements per current CE Mark labeling
- 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
- Do not meet any contraindications per current CE Mark labeling
- Body Mass Index (BMI) of > 35
- Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- 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
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Klinik für HNO-Heilkunde/HNO-Schlaflabor
Lübeck, 23538
Universitäts-HNO-Klinik Mannheim
Mannheim, D-68135
Klinikum rechts der Isar der Technischen Universität München
München, D-81675
About this study
Official title: Inspire® Upper Airway Stimulation System: Randomized Control Trial / European Post-Market Study
The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.
Read the detailed description
This study is a prospective, multi-center, randomized controlled study with a delayed start arm, conducted under a common implant protocol.
Up to 40 study subjects will be implanted at up to six centers in Europe. Subjects will be evaluated at baseline, implant, post-op (randomized) and 1-, 2-, 3,- 4- and 6-months post-implant.
Baseline data will include collection of demographics and medical history, completion of a physical exam, Functional Tongue Exam (FTE), and subject quality of life (QoL) questionnaires (Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS)). Adverse event data will be collected from the time of baseline testing through the 6-month study follow-up.
Implant eligibility assessments will include home sleep testing (HST), a surgical consultation and a drug induced sedated endoscopy (DISE) to determine if the subject is a qualified candidate for implant.
Subjects meeting all baseline and pre-screening requirements will be implanted with the Inspire system. Intra- and post- operative procedure data will be collected. Subjects will be seen for a post-operative check one week after implant. During this visit, subjects will be randomized 1:1 to the ACTIVE group or the DELAY group. However, the Inspire system will not be activated (turned "on") during the first month post-implant to allow for post-surgical healing.
Only subjects randomized to the ACTIVE group will return for the 1-month follow-up visit at which time the device will be activated (turned "on"). The subjects will be provided with a patient remote and instructed on its use. These ACTIVE arm subjects will be instructed to use their Inspire system on a nightly basis and return for a 2-month visit for an in-laboratory sleep study to complete device titration.
All subjects (ACTIVE and DELAY) return for the 3-month visit to complete a HST (DELAY subjects' therapy will remain off during the HST). In addition, QoL and patient satisfaction surveys, Functional Tongue Exam (FTE), and general health assessments, including adverse event review, will be collected. Subjects in the DELAY arm will have their therapy activated at the end of the 3 month visit, and return for a 4-month visit for an in-laboratory sleep study to complete device titration. All subjects will return for a 6-month and final visit where a two-night HST will be completed. In addition, QoL and patient satisfaction surveys, physical exam and FTE data will be collected; a device check will be completed as well as adverse event review. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis. Safety data will be collected throughout the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Inspire® Upper Airway Stimulation (UAS) System
- Keywords
- Obstructive Sleep Apnea, 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® Upper Airway Stimulation (UAS) SystemDevice
Also called Inspire® Therapy
This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System. This is a permanent, implantable therapy device, which consists of three implantable components: an implantable pulse generator (IPG), a stimulation lead, and a sensing lead. In addition, the patient receives a handheld remote 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® Upper Airway Stimulation (UAS) System. Receives: Device: Inspire® Upper Airway Stimulation (UAS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline OSA at 3 Months
The percent of apnea hypopnea index (AHI) reduction will be used as a primary endpoint to quantify the effects of the Inspire therapy on OSA between the 'Active' therapy (ACTIVE) and 'Delayed Start' therapy (DELAY). The percent of AHI reduction is the percent change between baseline AHI at the pre-implant sleep study and AHI at the 3-month post-implant sleep study.
Measured: 3 months post-implant
Secondary outcomes (4)
Number of Reported SAEs / Procedure & Device Related AEs
Safety of the therapy will be assessed via the description of all reported SAEs and all procedure- or device-related AEs. Adverse events will be summarized by seriousness, severity, relatedness to the device and/or procedure and temporal relationship to the procedure. No formal statistical hypotheses will be tested. Only device- or procedure-related AEs will be collected in this post-market study.
Measured: 6 months post-implant
Change from Baseline OSA at 6 Months
AHI at the 6-month follow-up will be compared to the AHI at baseline in both the ACTIVE and DELAY groups.
Measured: 6 months post-implant
Change from Baseline Breathing Indices at 6 Months
Sleep disordered breathing indices at the 6-month follow-up will be compared to the breathing indices at baseline.
Measured: 6 months post-implant
Change from Baseline Quality of Life Questionnaires (QoL)
Quality of Life (QoL) questionnaires at the 6-month visit will be compared to the QoL questionnaires at baseline.
Measured: 6 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Study halted due to low recruitment. Reimbursement changes require a larger study with additional centers and therefore, a new study planned as replacement.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clemens Heiser, Dr. med., Principal investigator, Technical University of MunichJoachim T Maurer, OA Dr. med., Principal investigator, Universitäts-HNO-Klinik MannheimArmin Steffen, PD Dr. med., Principal investigator, Klinik für HNO-Heilkunde/HNO-SchlaflaborOlivier Vanderveken, Prof. dr., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675816
- Sponsor's protocol ID
- 2015-001
- Acronym
- RCT
- Status last verified
- Aug 2016
- First submitted
- 28 Jan 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspire® Upper Airway Stimulation System: Randomized Control Trial / European Post-Market Study
- ClinicalTrials.gov ID
- NCT02675816
- Acronym / sponsor ID
- RCT / 2015-001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, OSA, neurostimulation, hypoglossal nerve, tongue, upper airway stimulation, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted due to low recruitment. Reimbursement changes require a larger study with additional centers and therefore, a new study planned as replacement.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Feb 2016 (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 post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe obstructive sleep apnea (OSA) using a randomized controlled trial design.
Detailed description
This study is a prospective, multi-center, randomized controlled study with a delayed start arm, conducted under a common implant protocol.
Up to 40 study subjects will be implanted at up to six centers in Europe. Subjects will be evaluated at baseline, implant, post-op (randomized) and 1-, 2-, 3,- 4- and 6-months post-implant.
Baseline data will include collection of demographics and medical history, completion of a physical exam, Functional Tongue Exam (FTE), and subject quality of life (QoL) questionnaires (Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS)). Adverse event data will be collected from the time of baseline testing through the 6-month study follow-up.
Implant eligibility assessments will include home sleep testing (HST), a surgical consultation and a drug induced sedated endoscopy (DISE) to determine if the subject is a qualified candidate for implant.
Subjects meeting all baseline and pre-screening requirements will be implanted with the Inspire system. Intra- and post- operative procedure data will be collected. Subjects will be seen for a post-operative check one week after implant. During this visit, subjects will be randomized 1:1 to the ACTIVE group or the DELAY group. However, the Inspire system will not be activated (turned "on") during the first month post-implant to allow for post-surgical healing.
Only subjects randomized to the ACTIVE group will return for the 1-month follow-up visit at which time the device will be activated (turned "on"). The subjects will be provided with a patient remote and instructed on its use. These ACTIVE arm subjects will be instructed to use their Inspire system on a nightly basis and return for a 2-month visit for an in-laboratory sleep study to complete device titration.
All subjects (ACTIVE and DELAY) return for the 3-month visit to complete a HST (DELAY subjects' therapy will remain off during the HST). In addition, QoL and patient satisfaction surveys, Functional Tongue Exam (FTE), and general health assessments, including adverse event review, will be collected. Subjects in the DELAY arm will have their therapy activated at the end of the 3 month visit, and return for a 4-month visit for an in-laboratory sleep study to complete device titration. All subjects will return for a 6-month and final visit where a two-night HST will be completed. In addition, QoL and patient satisfaction surveys, physical exam and FTE data will be collected; a device check will be completed as well as adverse event review. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis. Safety data will be collected throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspire® (UAS) System | Other | Device: Inspire® Upper Airway Stimulation (UAS) SystemThis is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the requirements per current CE Mark labeling
- 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
Key exclusion criteria (7 listed)
- Do not meet any contraindications per current CE Mark labeling
- Body Mass Index (BMI) of > 35
- Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
- 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
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 (UAS) SystemAlso: Inspire® TherapyThis is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System. This is a permanent, implantable therapy device, which consists of three implantable components: an implantable pulse generator (IPG), a stimulation lead, and a sensing lead. In addition, the patient receives a handheld remote to activate the therapy | Device | Inspire® (UAS) System |
Primary outcome
Change from Baseline OSA at 3 Months
Time frame: 3 months post-implant
The percent of apnea hypopnea index (AHI) reduction will be used as a primary endpoint to quantify the effects of the Inspire therapy on OSA between the 'Active' therapy (ACTIVE) and 'Delayed Start' therapy (DELAY). The percent of AHI reduction is the percent change between baseline AHI at the pre-implant sleep study and AHI at the 3-month post-implant sleep study.
4 secondary outcomes
Number of Reported SAEs / Procedure & Device Related AEs
Time frame: 6 months post-implant
Change from Baseline OSA at 6 Months
Time frame: 6 months post-implant
Change from Baseline Breathing Indices at 6 Months
Time frame: 6 months post-implant
Change from Baseline Quality of Life Questionnaires (QoL)
Time frame: 6 months post-implant
Results and safety
The study was stopped early (reason given: Study halted due to low recruitment. Reimbursement changes require a larger study with additional centers and therefore, a new study planned as replacement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
Clemens Heiser, Dr. med. principal investigator
Technical University of Munich
Joachim T Maurer, OA Dr. med. principal investigator
Universitäts-HNO-Klinik Mannheim
Armin Steffen, PD Dr. med. principal investigator
Klinik für HNO-Heilkunde/HNO-Schlaflabor
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inspire® Upper Airway Stimulation (UAS) System in people with Obstructive Sleep Apnea, run by Inspire Medical Systems, Inc. at 4 sites in 2 countries.
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 4 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: stopped early, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study halted due to low recruitment. Reimbursement changes require a larger study with additional centers and therefore, a new study planned as replacement.). 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?
Change from Baseline OSA at 3 Months (time frame: 3 months post-implant). 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 11 Aug 2016.