Obstructive Sleep ApneaNCT03756805
Upper Airway Stimulation Versus Continuous Positive Airway Pressure
A study testing upper airway stimulation and continuous positive airway pressure in people with Obstructive Sleep Apnea, run by Technical University of Munich at 1 site in Germany.
Trial summary
Standard therapy in patients with obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP). 30% to 50% are not adherent to this therapy and need an alternative treatment. Hypoglossal nerve stimulation or selective upper airway stimulation has been developed since several years. 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 and continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jul 2018to 31 Dec 2019
- 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
- All consecutive patients who either received UAS implantation (Inspire therapy) in our Department of Otorhinolaryngology, Head and Neck Surgery at the Klinikum rechts der Isar and all patients who received a CPAP therapy since July 2013, are invited to participate in this clinical examination.
Who cannot join
- patients with the age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Upper Airway Stimulation Compared to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: a Prospective Cohort Study
Standard therapy in patients with obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP). 30% to 50% are not adherent to this therapy and need an alternative treatment. Hypoglossal nerve stimulation or selective upper airway stimulation has been developed since several years. The aim of this clinical trial is to compare both treatments with each other.
Read the detailed description
6% to 13% of the western industrialized population suffer from obstructive sleep apnea (OSA). During sleep in the pharyngeal airway a relaxation of the muscles occurs with increasing depth of sleep. Finally, this relaxation, due to the anatomical conditions, lead to obstructions of the respiratory tract, resulting in respiratory arrest (apnea) and minor respiratory changes such as hypopneas or flow limitations. The symptoms of this disease manifest themselves with varying degrees. Increased daytime sleepiness, snoring, and increased risk of cardiovascular disease can result. A significant reduction in overall quality of life can be associated with OSAS. The gold standard treatment for obstructive sleep apnea is CPAP (continuous positive airway pressure). But only about 50% to 70% of patients continue to use their device after 2 years of initial CPAP therapy. This means that 30% to 50% of patients are no longer cared for their obstructive sleep apnea. A certain proportion of younger patients, in particular, reject nocturnal ventilation therapy with CPAP from the beginning. For these patients selective upper airway stimulation (UAS) is a therapy option.
Therefore the patient receives surgically a subcutaneous stimulation device under the clavicle, which receives a signal from a respiratory sensor to selectively stimulate the hypoglossal nerve. The respiratory sensor is located in the 4th or 5th intercostal space between the patient's external and internal rib muscles. This can be used to record the patient's breathing, which allows a matched stimulation of the hypoglossal nerve. The actual stimulation lead is attached to the medial branches of the hypoglossal nerve, which are responsible for the protrusion of the tongue, in order to enable appropriate stimulation.
In this prospective cohort study, selective upper airway stimulation (UAS) will now be compared with CPAP therapy. Patients receiving CPAP therapy are compared to UAS patients who receive an upper airway stimulation. Both methods are procedures established in clinical routine, and during this investigation, the general clinical course is not deviated. Randomization does not occur because CPAP therapy is a conservative therapy and UAS therapy is a surgical therapy. Furthermore, for UAS therapy, there must be a CPAP incompliance, so that a surgical concept is justified. The CPAP group should comply with the body mass index and age of the UAS group.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- upper airway stimulation, continuous positive airway pressure
- Keywords
- obstructive sleep apnea, hypoglossal nerve stimulation, upper airway stimulation, surgical treatment sleep apnea
- 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
One group of patients with UAS
continuous positive airway pressureDevice
One group of patients with CPAP
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (CPAP) | Active comparator | Patient, who are receiving a CPAP Receives: Device: continuous positive airway pressure |
| Group 2 (UAS) | Experimental | Patient, who are receiving a device for upper airway stimulation Receives: Device: upper airway stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
Apnea Hypopnea Index measured in events per hour
Measured: reduction from baseline to 12 months
ODI
Oxygen desaturation index measured in events per hour
Measured: reduction from baseline to 12 months
Secondary outcomes (3)
ESS
Epworth Sleepiness Scale
Measured: improvement from baseline to 12 months
FOSQ
Functional Outcome of Sleep Questionnaire
Measured: improvement from baseline to 12 months
Usage
Usage Hour per Night
Measured: usage hours per night at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start6 Jul 2018
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with moderate to severe sleep apnea (apnea-hypopnea index (AHI) between 15 / h and 65 / h) are included in the period 2014-2018. The patients are assigned to two groups: group 1, who are receiving PAP therapy and group 2, who are receiving upper airway stimulation. All patients receive polysomnography (PSG) in the sleep laboratory prior to therapy and are followed up on average 12 months after initiation of therapy by PSG or a home sleep test. This protocol is close to the daily clinical routine.
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756805
- Sponsor's protocol ID
- UAS vs. CPAP
- Status last verified
- Mar 2020
- First submitted
- 27 Nov 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heiser C, Steffen A, Strollo PJ Jr, Giaie-Miniet C, Vanderveken OM, Hofauer B. Hypoglossal nerve stimulation versus positive airway pressure therapy for obstructive sleep apnea. Sleep Breath. 2023 May;27(2):693-701. doi: 10.1007/s11325-022-02663-6. Epub 2022 Jul 2.
PubMed 35779166
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Upper Airway Stimulation Compared to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03756805
- Acronym / sponsor ID
- UAS vs. CPAP
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, hypoglossal nerve stimulation, upper airway stimulation, surgical treatment sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 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.
Standard therapy in patients with obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP). 30% to 50% are not adherent to this therapy and need an alternative treatment. Hypoglossal nerve stimulation or selective upper airway stimulation has been developed since several years. The aim of this clinical trial is to compare both treatments with each other.
Detailed description
6% to 13% of the western industrialized population suffer from obstructive sleep apnea (OSA). During sleep in the pharyngeal airway a relaxation of the muscles occurs with increasing depth of sleep. Finally, this relaxation, due to the anatomical conditions, lead to obstructions of the respiratory tract, resulting in respiratory arrest (apnea) and minor respiratory changes such as hypopneas or flow limitations. The symptoms of this disease manifest themselves with varying degrees. Increased daytime sleepiness, snoring, and increased risk of cardiovascular disease can result. A significant reduction in overall quality of life can be associated with OSAS. The gold standard treatment for obstructive sleep apnea is CPAP (continuous positive airway pressure). But only about 50% to 70% of patients continue to use their device after 2 years of initial CPAP therapy. This means that 30% to 50% of patients are no longer cared for their obstructive sleep apnea. A certain proportion of younger patients, in particular, reject nocturnal ventilation therapy with CPAP from the beginning. For these patients selective upper airway stimulation (UAS) is a therapy option.
Therefore the patient receives surgically a subcutaneous stimulation device under the clavicle, which receives a signal from a respiratory sensor to selectively stimulate the hypoglossal nerve. The respiratory sensor is located in the 4th or 5th intercostal space between the patient's external and internal rib muscles. This can be used to record the patient's breathing, which allows a matched stimulation of the hypoglossal nerve. The actual stimulation lead is attached to the medial branches of the hypoglossal nerve, which are responsible for the protrusion of the tongue, in order to enable appropriate stimulation.
In this prospective cohort study, selective upper airway stimulation (UAS) will now be compared with CPAP therapy. Patients receiving CPAP therapy are compared to UAS patients who receive an upper airway stimulation. Both methods are procedures established in clinical routine, and during this investigation, the general clinical course is not deviated. Randomization does not occur because CPAP therapy is a conservative therapy and UAS therapy is a surgical therapy. Furthermore, for UAS therapy, there must be a CPAP incompliance, so that a surgical concept is justified. The CPAP group should comply with the body mass index and age of the UAS group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with moderate to severe sleep apnea (apnea-hypopnea index (AHI) between 15 / h and 65 / h) are included in the period 2014-2018. The patients are assigned to two groups: group 1, who are receiving PAP therapy and group 2, who are receiving upper airway stimulation. All patients receive polysomnography (PSG) in the sleep laboratory prior to therapy and are followed up on average 12 months after initiation of therapy by PSG or a home sleep test. This protocol is close to the daily clinical routine.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (CPAP) | Active comparator | Device: continuous positive airway pressurePatient, who are receiving a CPAP |
| Group 2 (UAS) | Experimental | Device: upper airway stimulationPatient, who are receiving a device for upper airway stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients who either received UAS implantation (Inspire therapy) in our Department of Otorhinolaryngology, Head and Neck Surgery at the Klinikum rechts der Isar and all patients who received a CPAP therapy since July 2013, are invited to participate in this clinical examination.
Key exclusion criteria (1 listed)
- patients with the age under 18 years
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: InspireOne group of patients with UAS | Device | Group 2 (UAS) |
| continuous positive airway pressureOne group of patients with CPAP | Device | Group 1 (CPAP) |
Primary outcome
AHI
Time frame: reduction from baseline to 12 months
Apnea Hypopnea Index measured in events per hour
ODI
Time frame: reduction from baseline to 12 months
Oxygen desaturation index measured in events per hour
3 secondary outcomes
ESS
Time frame: improvement from baseline to 12 months
FOSQ
Time frame: improvement from baseline to 12 months
Usage
Time frame: usage hours per night at 12 months
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 25 Mar 2020.
- Derived from this study: PubMed 35779166Heiser C, Steffen A, Strollo PJ Jr, Giaie-Miniet C, Vanderveken OM, Hofauer B. Hypoglossal nerve stimulation versus positive airway pressure therapy for obstructive sleep apnea. Sleep Breath. 2023 May;27(2):693-701. doi: 10.1007/s11325-022-02663-6. Epub 2022 Jul 2.
- Official Website of the DepartmentLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and continuous positive airway pressure 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 1 inclusion and 1 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 25 Mar 2020. 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. 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?
AHI (time frame: reduction from baseline to 12 months). 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 NCT03756805, 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 25 Mar 2020.