Obstructive Sleep ApneaEFFECTNCT03760328
Effect of Upper Airway Stimulation in Patients With Obstructive Sleep Apnea
A study testing Upper Airway Stimulation in people with Obstructive Sleep Apnea, run by Technical University of Munich at 1 site in Germany.
Trial summary
Upper Airway Stimulation is a new therapy, which is available for patients with obstructive sleep apnea, who are non-compliant to the standard treatment continuous positive airway pressure (CPAP) therapy. 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?
- Upper Airway Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2019to 30 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Otherwise healthy subjects that are at least 18 years old and:
- Have been implanted and using the Inspire Therapy for at least six months
- Willing and capable to undergo three in-lab PSGs in a one-month timeframe
- Willing and capable of having reduced Inspire stimulation for one week
- Willing and capable of providing informed consent
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this clinical investigation:
- Unwilling to complete three in-lab PSGs within a 1-month timeframe
- Any other reason the investigator deems subject is unfit for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Upper Airway Stimulation: A Randomized Controlled Crossover Study
Upper Airway Stimulation is a new therapy, which is available for patients with obstructive sleep apnea, who are non-compliant to the standard treatment continuous positive airway pressure (CPAP) therapy. This study is a prospective, multi-center, double-blinded, randomized crossover study conducted under a common protocol. The study visits include baseline with an in-laboratory polysomnography (PSG) after six months of therapy usage, followed by visits and in-lab PSGs at 1 and 2-weeks where the Therapy stimulation will be changed at each, according to randomization. The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
Read the detailed description
Obstructive Sleep Apnea (OSA) is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousal from sleep. The most common symptom of OSA is excessive daytime sleepiness. Recent studies have also shown clear association of OSA with the development of obesity, hypertension diabetes mellitus, and congestive heart failure. Approximately 13% men and 6% women have moderate to severe OSA (apnea hypopnea index, AHI ≥ 15) in the US.
The efficacy of therapies for OSA, and in particular, continuous positive airway pressure (CPAP) has been limited due to patient intolerance, poor patient selection, or limited response to the therapy.
The Inspire Upper Airway Stimulation (UAS) system is intended to prevent upper airway obstruction by stimulating the hypoglossal nerve synchronous with respiration [7].
The Inspire system is comprised of the following components:
- Inspire Upper Airway Stimulator (Implantable Pulse Generator (IPG))
- Inspire Stimulation Lead
- Inspire Sensing Lead
- External programmers used with the system are:
- Inspire Programmer (physician programmer)
- Inspire Patient Programmer (patient remote)
The Inspire system received CE Mark in 2010 (CE Certificate No. 562872) providing the regulatory authority to provide the device in a commercial setting. Furthermore, this study will be conducted within the CE marked intended use of the Inspire system and will not involve any additional stressful or invasive tests.
The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Upper Airway Stimulation
- 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.
Upper Airway StimulationDevice
Also called Inspire
hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway
| Study group | Role | What they receive |
|---|---|---|
| therapeutic stimulation | Active comparator | Therapeutic Stimulation: optimal therapy setting for home use Receives: Device: Upper Airway Stimulation |
| sham stimulation | Sham comparator | Sham Stimulation (Control Group): stimulation voltage programmed at 0.1 volts Receives: Device: Upper Airway Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AHI from Baseline to Visit 1 and Visit 2
Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI in this study will be determined by the AHI score at Visit 1 and Visit 2 compared with the baseline score.
Measured: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in ESS from Baseline to Visit 1 and Visit 2
The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. The ESS efficacy endpoint will be determined by the ESS score at Visit 1 and Visit 2 as compared to baseline.
Measured: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Secondary outcomes (5)
Change in FOSQ from Baseline to Visit 1 and Visit 2
The Functional Outcomes of Sleep Questionnaire (FOSQ) is a validated instrument to assess the effect of a subject's daytime sleepiness on activities of ordinary living. The FOSQ endpoint will be determined by the FOSQ score at Visit 1 and Visit 2 as compared to baseline.
Measured: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in Snoring Intensity from Baseline to Visit 1 and Visit 2
Snoring Intensity will be measured by using a visual analoge scale from 0 (no snoring) to 10 (heavy snoring). The snoring intensity endpoint will be determined by the visual analogue scale at Visit 1 and Visit 2 as compared to baseline.
Measured: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Therapy Adherence
Therapy use, reported as hours of use per week, is record by Inspire device and can be collected upon interrogation of the device in the clinic. This value can be used to quantify device use and adherence over the investigated time period.
Measured: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in ODI from Baseline to Visit 1 and Visit 2
Oxygen Desaturation Index (ODI) is a measure of OSA severity. The ODI will be determined by the ODI score at Visit 1 and Visit 2 as compared with to baseline
Measured: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in Clinical Global Impression (CGI-I) from Baseline to Visit 1 and Visit 2
The CGI-I is a seven point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
Measured: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start16 Jan 2019
- Primary completion31 May 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Technical University of MunichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a prospective, multi-center, randomized, crossover study, conducted under a common protocol. Subjects will be enrolled after they have been implanted and using the Inspire therapy (Inspire II/IV, Inspire Medical Systems, Maple Grove, USA) for at least six months. Participants will be randomized to one of two groups: therapeutic stimulation or sham stimulation. During the second phase of the study therapy settings of the stimulation system will be adjusted to crossover.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsmedizin Mannheim, University of Luebeck
- Responsible party
- Sponsor
- Investigators
- Clemens Heiser, M.D., Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760328
- Sponsor's protocol ID
- EFFECT
- Acronym
- EFFECT
- Status last verified
- Oct 2020
- First submitted
- 27 Nov 2018
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steffen A, Moritz FJ, Konig IR, Suurna MV, Bruggemann N. Electric field aspects in hypoglossal nerve stimulation for obstructive sleep apnea: A bilateral electrophysiological evaluation of unilateral electrode configuration changes. J Sleep Res. 2023 Feb;32(1):e13592. doi: 10.1111/jsr.13592. Epub 2022 May 21.
PubMed 35596592
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upper Airway Stimulation: A Randomized Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03760328
- Acronym / sponsor ID
- EFFECT / EFFECT
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Universitätsmedizin Mannheim, University of Luebeck
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 30 Nov 2018 (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.
Upper Airway Stimulation is a new therapy, which is available for patients with obstructive sleep apnea, who are non-compliant to the standard treatment continuous positive airway pressure (CPAP) therapy. This study is a prospective, multi-center, double-blinded, randomized crossover study conducted under a common protocol. The study visits include baseline with an in-laboratory polysomnography (PSG) after six months of therapy usage, followed by visits and in-lab PSGs at 1 and 2-weeks where the Therapy stimulation will be changed at each, according to randomization. The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
Detailed description
Obstructive Sleep Apnea (OSA) is characterized by recurrent episodes of airflow obstruction in the upper airway that results in oxygen desaturations and arousal from sleep. The most common symptom of OSA is excessive daytime sleepiness. Recent studies have also shown clear association of OSA with the development of obesity, hypertension diabetes mellitus, and congestive heart failure. Approximately 13% men and 6% women have moderate to severe OSA (apnea hypopnea index, AHI ≥ 15) in the US.
The efficacy of therapies for OSA, and in particular, continuous positive airway pressure (CPAP) has been limited due to patient intolerance, poor patient selection, or limited response to the therapy.
The Inspire Upper Airway Stimulation (UAS) system is intended to prevent upper airway obstruction by stimulating the hypoglossal nerve synchronous with respiration [7].
The Inspire system is comprised of the following components:
- Inspire Upper Airway Stimulator (Implantable Pulse Generator (IPG))
- Inspire Stimulation Lead
- Inspire Sensing Lead
- External programmers used with the system are:
- Inspire Programmer (physician programmer)
- Inspire Patient Programmer (patient remote)
The Inspire system received CE Mark in 2010 (CE Certificate No. 562872) providing the regulatory authority to provide the device in a commercial setting. Furthermore, this study will be conducted within the CE marked intended use of the Inspire system and will not involve any additional stressful or invasive tests.
The objective of this randomized controlled crossover study is to assess treatment effect of Inspire UAS in patients at different time points with two different therapy settings. This study will provide additional clinical evidence of Inspire UAS for treatment of moderate to severe OSA using a randomized controlled crossover trial design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, multi-center, randomized, crossover study, conducted under a common protocol. Subjects will be enrolled after they have been implanted and using the Inspire therapy (Inspire II/IV, Inspire Medical Systems, Maple Grove, USA) for at least six months. Participants will be randomized to one of two groups: therapeutic stimulation or sham stimulation. During the second phase of the study therapy settings of the stimulation system will be adjusted to crossover.
| Arm | Type | Receives |
|---|---|---|
| therapeutic stimulation | Active comparator | Device: Upper Airway StimulationTherapeutic Stimulation: optimal therapy setting for home use |
| sham stimulation | Sham comparator | Device: Upper Airway StimulationSham Stimulation (Control Group): stimulation voltage programmed at 0.1 volts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Otherwise healthy subjects that are at least 18 years old and:
Key exclusion criteria (3 listed)
- Subjects who meet any of the following criteria will be excluded from this clinical investigation:
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 |
|---|---|---|
| Upper Airway StimulationAlso: Inspirehypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway | Device | sham stimulation, therapeutic stimulation |
Primary outcome
Change in AHI from Baseline to Visit 1 and Visit 2
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Apnea Hypopnea Index (AHI) is a measure of OSA severity. The AHI in this study will be determined by the AHI score at Visit 1 and Visit 2 compared with the baseline score.
Change in ESS from Baseline to Visit 1 and Visit 2
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
The Epworth Sleepiness Scale (ESS) is a validated instruction that rates a subject's daytime sleepiness. The ESS efficacy endpoint will be determined by the ESS score at Visit 1 and Visit 2 as compared to baseline.
5 secondary outcomes
Change in FOSQ from Baseline to Visit 1 and Visit 2
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in Snoring Intensity from Baseline to Visit 1 and Visit 2
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Therapy Adherence
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in ODI from Baseline to Visit 1 and Visit 2
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Change in Clinical Global Impression (CGI-I) from Baseline to Visit 1 and Visit 2
Time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 35596592Steffen A, Moritz FJ, Konig IR, Suurna MV, Bruggemann N. Electric field aspects in hypoglossal nerve stimulation for obstructive sleep apnea: A bilateral electrophysiological evaluation of unilateral electrode configuration changes. J Sleep Res. 2023 Feb;32(1):e13592. doi: 10.1111/jsr.13592. Epub 2022 May 21.
- Homepage for DepartmentLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Clemens Heiser, M.D. principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Airway Stimulation in people with Obstructive Sleep Apnea, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in AHI from Baseline to Visit 1 and Visit 2 (time frame: Baseline through Visit 1 (1 week) and Visit 2 (2 weeks)). 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?
On the ClinicalTrials.gov record for NCT03760328, which also lists 1 linked publication.
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 Nov 2023.