Obstructive Sleep ApneaPhase 1NCT01117064
Neuromodulation Therapy Device for the Treatment of Sleep Apnea
A Phase 1 study testing Neuromodulation Therapy Device (NMTD) in people with Obstructive Sleep Apnea, run by Mayo Clinic at 1 site in United States.
Trial summary
We are looking to test a novel device in the treatment of Obstructive Sleep Apnea (OSA). Rather than using positive pressure to open the airways, we are testing a device that delivers an auditory tone to affect neuromodulation. We will test its efficacy in treating OSA while minimizing sleep disturbance. 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?
- Neuromodulation Therapy Device (NMTD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 1
- 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
- Subjects 18 years or older
- Completed a comprehensive Sleep Medicine evaluation and a standard split-night polysomnogram
- Able to give informed consent
- Confirmed diagnosis of OSA
- Positive airway pressure device naive
Who cannot join
- Unsuccessful CPAP titration
- Inability to detect screening tone in either ear without the use of hearing aid
- Inability to tolerate a 37 dB tone
- Need for nocturnal oxygen or non-invasive positive pressure ventilation due to hypoventilation/hypercapnia
- Predominantly mixed or central apneas or those who develop complex sleep apnea during the PSG
- Neurologic disorders such as seizure disorder or narcolepsy
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- Psychiatric disorders currently not under adequate control
- Need for nurse or other's assistance during the night due to problems of nocturnal confusion, delirium, or other conditions that would preclude the subject from wearing the device all night
- Pregnancy (will be tested)
Trial locations and contacts
1 site in 1 country.
About this study
We are looking to test a novel device in the treatment of Obstructive Sleep Apnea (OSA). Rather than using positive pressure to open the airways, we are testing a device that delivers an auditory tone to affect neuromodulation. We will test its efficacy in treating OSA while minimizing sleep disturbance. As this device is much less cumbersome to wear, we hope this therapy device will also improve compliance with treatment.
Read the detailed description
Neuromodulation Therapy Device for the Treatment of Sleep Apnea
Obstructive sleep apnea (OSA) is a common public health problem with severe health consequences that substantially raises the risk of cardiovascular and cerebrovascular death. Continuous positive airway pressure (CPAP) is currently the most effective treatment option, yet up to half of patients fail to tolerate CPAP and require other approaches. Novel treatments offering alternatives to CPAP are thus sorely needed by those suffering from OSA. The Neuromodulation Therapy Device (NMTD) is a novel potential therapy for OSA. The main goal of our project is to evaluate the efficacy, tolerability, and safety of NMTD in patients with OSA.
Hypothesis 1 - The NMTD device is capable of reducing AHI.
OSA severity is indexed by apnea-hypopnea index (AHI), the number of apnea/hypopnea events occurring hourly during sleep. Our first aim is to determine NMTD's operating characteristics for treatment of OSA. The optimal duration of a detected apnea/hypopnea event before NMTD responds must first be determined. Additional adjustable features include sensitivity of respiratory event sensor, as well as pulse duration, frequency, and intensity of the delivered auditory tone. Since independent adjustment of each of the 4 parameters is not feasible, our screening analysis will test two variables at a time to identify which variables most effectively reduce AHI. This will allow for more practical titration during a therapeutic sleep study and more generalizable application of the device.
Hypothesis 2 - Modified NMTD is as effective and tolerable as CPAP in OSA treatment.
Once Aim 1 is complete and effective NMTD settings have been identified, we will initiate a Phase II NMTD trial to assess efficacy and tolerability. The primary outcome variable will be AHI reduction by NMTD compared with CPAP during a repeat polysomnogram (PSG). We will randomly assign previously titrated CPAP vs. NMTD to each subject then compare the resultant AHI between the two devices. Tolerability will also be assessed by sleep efficiency, arousal index, and sleep architecture. While auditory stimuli below 90 dB threshold should not adversely affect sleep architecture and quality,1 intermittent stimuli given during different sleep stages have not been previously assessed. Therefore, we will monitor NMTD's influence on sleep architecture, arousal index, and sleep efficiency compared to the same variables during CPAP use, allowing us to examine whether NMTD affects sleep quality. We will also assess patient preference in using CPAP versus NMTD.
Hypothesis 3 - NMTD will maintain efficacy with repeated use.
Given the brain's plasticity, it is unknown whether the brain may adapt to such repeated auditory stimuli. Constant auditory stimuli may lead to adaptation, resulting in the stimuli being "ignored." NMTD's stimuli, however, are less likely to lead to significant adaptation since they are intermittent and somewhat random, dependent on apneic or hypopneic events. Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time. In the future, when more devices are available, we will plan on long-term evaluations.
We propose to test this novel device in the treatment of OSA. This device, if successful, will substantially expand the treatment options for OSA by offering an effective alternative to CPAP with the potential for improved treatment compliance.
Plan:
This is a prospective study evaluating the efficacy of the NMTD in the treatment of OSA.
The study is divided into three consecutive phases, representing the three aims. If eligible, participants will be assigned to the phase that is currently being studied.
- One PSG, using the NMTD all night (32 participants)
- One PSG, split between the NMTD and standard CPAP therapy, randomized as to which is first (20 participants)
- Two consecutive PSGs using the NMTD all night (20 participants) to assess stimulus-response extinction over time (20 participants) All participants will complete a questionnaire about their experience with the device.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Neuromodulation Therapy Device (NMTD)
- Keywords
- Sleep Apnea, OSA, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromodulation Therapy Device (NMTD)Device
Subjects will have an overnight PSG using CPAP (as previously titrated) for half of the night and NMTD the other half (this order will be randomized). we will monitor NMTD's influence on Apnea Hypopnea Index (AHI), sleep architecture, arousal index, and sleep efficiency compared to the same variables during CPAP use
Neuromodulation Therapy Device (NMTD)Device
Subjects will have an overnight PSG using the NMTD. This device detects reduced airflow via a polymer sensor. When such event is detected, a short burst of sound is administered via earphones. We will determine NMTD's operating characteristics for treatment of OSA. The optimal duration of a detected apnea/hypopnea event before NMTD responds must first be determined. Additional adjustable features include sensitivity of respiratory event sensor, as well as pulse duration, frequency, and intensity of the delivered auditory tone. Since independent adjustment of each of the 4 parameters is not feasible, our screening analysis will test two variables at a time to identify which variables most effectively reduce AHI.
Neuromodulation Therapy Device (NMTD)Device
Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time.
| Study group | Role | What they receive |
|---|---|---|
| NMTD adjustment testing | Active comparator | We will determine effective NMTD device settings for reducing AHI. Receives: Device: Neuromodulation Therapy Device (NMTD) |
| CPAP vs NMTD device | Active comparator | We will randomly assign previously titrated CPAP vs. NMTD to each subject then compare the resultant AHI between the two devices. Receives: Device: Neuromodulation Therapy Device (NMTD) |
| NMTD efficacy and tolerability | Active comparator | Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time. Receives: Device: Neuromodulation Therapy Device (NMTD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will determine effective device settings on the Neuromodulation Therapy Device (NMTD).
Measured: First year
Secondary outcomes (1)
We will compare the modified NMTD's efficacy and tolerability to that of CPAP in treating OSA.
Measured: Second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2011
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.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Dymedix Corporation
- Responsible party
- Principal investigator, John G. Park, Mayo Clinic
- Investigators
- John G. Park, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117064
- Sponsor's protocol ID
- 09-006804
- Status last verified
- May 2013
- First submitted
- 8 Feb 2010
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Therapy Device for the Treatment of Sleep Apnea
- ClinicalTrials.gov ID
- NCT01117064
- Acronym / sponsor ID
- 09-006804
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep Apnea, OSA, CPAP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Dymedix Corporation
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 May 2010 (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.
We are looking to test a novel device in the treatment of Obstructive Sleep Apnea (OSA). Rather than using positive pressure to open the airways, we are testing a device that delivers an auditory tone to affect neuromodulation. We will test its efficacy in treating OSA while minimizing sleep disturbance. As this device is much less cumbersome to wear, we hope this therapy device will also improve compliance with treatment.
Detailed description
Neuromodulation Therapy Device for the Treatment of Sleep Apnea
Obstructive sleep apnea (OSA) is a common public health problem with severe health consequences that substantially raises the risk of cardiovascular and cerebrovascular death. Continuous positive airway pressure (CPAP) is currently the most effective treatment option, yet up to half of patients fail to tolerate CPAP and require other approaches. Novel treatments offering alternatives to CPAP are thus sorely needed by those suffering from OSA. The Neuromodulation Therapy Device (NMTD) is a novel potential therapy for OSA. The main goal of our project is to evaluate the efficacy, tolerability, and safety of NMTD in patients with OSA.
Hypothesis 1 - The NMTD device is capable of reducing AHI.
OSA severity is indexed by apnea-hypopnea index (AHI), the number of apnea/hypopnea events occurring hourly during sleep. Our first aim is to determine NMTD's operating characteristics for treatment of OSA. The optimal duration of a detected apnea/hypopnea event before NMTD responds must first be determined. Additional adjustable features include sensitivity of respiratory event sensor, as well as pulse duration, frequency, and intensity of the delivered auditory tone. Since independent adjustment of each of the 4 parameters is not feasible, our screening analysis will test two variables at a time to identify which variables most effectively reduce AHI. This will allow for more practical titration during a therapeutic sleep study and more generalizable application of the device.
Hypothesis 2 - Modified NMTD is as effective and tolerable as CPAP in OSA treatment.
Once Aim 1 is complete and effective NMTD settings have been identified, we will initiate a Phase II NMTD trial to assess efficacy and tolerability. The primary outcome variable will be AHI reduction by NMTD compared with CPAP during a repeat polysomnogram (PSG). We will randomly assign previously titrated CPAP vs. NMTD to each subject then compare the resultant AHI between the two devices. Tolerability will also be assessed by sleep efficiency, arousal index, and sleep architecture. While auditory stimuli below 90 dB threshold should not adversely affect sleep architecture and quality,1 intermittent stimuli given during different sleep stages have not been previously assessed. Therefore, we will monitor NMTD's influence on sleep architecture, arousal index, and sleep efficiency compared to the same variables during CPAP use, allowing us to examine whether NMTD affects sleep quality. We will also assess patient preference in using CPAP versus NMTD.
Hypothesis 3 - NMTD will maintain efficacy with repeated use.
Given the brain's plasticity, it is unknown whether the brain may adapt to such repeated auditory stimuli. Constant auditory stimuli may lead to adaptation, resulting in the stimuli being "ignored." NMTD's stimuli, however, are less likely to lead to significant adaptation since they are intermittent and somewhat random, dependent on apneic or hypopneic events. Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time. In the future, when more devices are available, we will plan on long-term evaluations.
We propose to test this novel device in the treatment of OSA. This device, if successful, will substantially expand the treatment options for OSA by offering an effective alternative to CPAP with the potential for improved treatment compliance.
Plan:
This is a prospective study evaluating the efficacy of the NMTD in the treatment of OSA.
The study is divided into three consecutive phases, representing the three aims. If eligible, participants will be assigned to the phase that is currently being studied.
- One PSG, using the NMTD all night (32 participants)
- One PSG, split between the NMTD and standard CPAP therapy, randomized as to which is first (20 participants)
- Two consecutive PSGs using the NMTD all night (20 participants) to assess stimulus-response extinction over time (20 participants) All participants will complete a questionnaire about their experience with the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMTD adjustment testing | Active comparator | Device: Neuromodulation Therapy Device (NMTD)We will determine effective NMTD device settings for reducing AHI. |
| CPAP vs NMTD device | Active comparator | Device: Neuromodulation Therapy Device (NMTD)We will randomly assign previously titrated CPAP vs. NMTD to each subject then compare the resultant AHI between the two devices. |
| NMTD efficacy and tolerability | Active comparator | Device: Neuromodulation Therapy Device (NMTD)Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 18 years or older
- Completed a comprehensive Sleep Medicine evaluation and a standard split-night polysomnogram
- Able to give informed consent
- Confirmed diagnosis of OSA
- Positive airway pressure device naive
Key exclusion criteria (9 listed)
- Unsuccessful CPAP titration
- Inability to detect screening tone in either ear without the use of hearing aid
- Inability to tolerate a 37 dB tone
- Need for nocturnal oxygen or non-invasive positive pressure ventilation due to hypoventilation/hypercapnia
- Predominantly mixed or central apneas or those who develop complex sleep apnea during the PSG
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 |
|---|---|---|
| Neuromodulation Therapy Device (NMTD)Subjects will have an overnight PSG using CPAP (as previously titrated) for half of the night and NMTD the other half (this order will be randomized). we will monitor NMTD's influence on Apnea Hypopnea Index (AHI), sleep architecture, arousal index, and sleep efficiency compared to the same variables during CPAP use | Device | CPAP vs NMTD device |
| Neuromodulation Therapy Device (NMTD)Subjects will have an overnight PSG using the NMTD. This device detects reduced airflow via a polymer sensor. When such event is detected, a short burst of sound is administered via earphones. We will determine NMTD's operating characteristics for treatment of OSA. The optimal duration of a detected apnea/hypopnea event before NMTD responds must first be determined. Additional adjustable features include sensitivity of respiratory event sensor, as well as pulse duration, frequency, and intensity of the delivered auditory tone. Since independent adjustment of each of the 4 parameters is not feasible, our screening analysis will test two variables at a time to identify which variables most effectively reduce AHI. | Device | NMTD adjustment testing |
| Neuromodulation Therapy Device (NMTD)Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time. | Device | NMTD efficacy and tolerability |
Primary outcome
We will determine effective device settings on the Neuromodulation Therapy Device (NMTD).
Time frame: First year
1 secondary outcome
We will compare the modified NMTD's efficacy and tolerability to that of CPAP in treating OSA.
Time frame: Second year
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 29 May 2013.
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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.
John G. Park, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neuromodulation Therapy Device (NMTD) in people with Obstructive Sleep Apnea, run by Mayo Clinic at 1 site 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 5 inclusion and 9 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 29 May 2013. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
We will determine effective device settings on the Neuromodulation Therapy Device (NMTD). (time frame: First year). 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 29 May 2013.