Obstructive Sleep ApneaNCT05881512
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
A study testing Transcutaneous Upper Airway Stimulation Device in people with Obstructive Sleep Apnea and OSA, run by Somnial Inc at 1 site in United States.
Trial summary
Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, OSA
- What is being tested?
- Transcutaneous Upper Airway Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 22 Feb 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA
- In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, <25% of the respiratory events on the diagnostic PSG can be attributed to central apneas
- BMI less than or equal to 32
Who cannot join
- No or mild OSA (AHI <15/h) or very severe OSA (AHI >50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA.
- Patients who are cachectic (BMI <18.5 kg/m2) or obese (BMI >32 kg/m2).
- Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers.
- Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.
Trial locations and contacts
1 site in 1 country.
About this study
Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).
- Conditions
- Obstructive Sleep Apnea, OSA
- Being tested
- Transcutaneous Upper Airway Stimulation Device
- 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.
Transcutaneous Upper Airway Stimulation DeviceDevice
Also called TUAS
Multiple frequency stimulation of the hypoglossal nerve
| Study group | Role | What they receive |
|---|---|---|
| TUAS | Experimental | Transcutaneous upper airway stimulation Receives: Device: Transcutaneous Upper Airway Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
Episodes of apnea and/or hypopnea scored during the course of sleep study
Measured: Overnight (day 1)
Secondary outcomes (1)
Arterial Oxygen Saturation (SaO2)
SaO2 levels during the course of sleep study compared to baseline
Measured: Overnight (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start12 Sep 2022
- Primary completion18 Sep 2022
- Study completion22 Feb 2023
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somnial Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lee Shangold, MD, Principal investigator, ENT & Allergy Associates, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881512
- Sponsor's protocol ID
- SOMN-001
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05881512
- Acronym / sponsor ID
- SOMN-001
- Conditions
- Obstructive Sleep Apnea, OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Somnial IncIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 18 Sep 2022 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 31 May 2023 (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.
Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TUAS | Experimental | Device: Transcutaneous Upper Airway Stimulation DeviceTranscutaneous upper airway stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA
- In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, <25% of the respiratory events on the diagnostic PSG can be attributed to central apneas
Key exclusion criteria (4 listed)
- No or mild OSA (AHI <15/h) or very severe OSA (AHI >50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA.
- Patients who are cachectic (BMI <18.5 kg/m2) or obese (BMI >32 kg/m2).
- Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers.
- Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.
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 |
|---|---|---|
| Transcutaneous Upper Airway Stimulation DeviceAlso: TUASMultiple frequency stimulation of the hypoglossal nerve | Device | TUAS |
Primary outcome
Apnea Hypopnea Index
Time frame: Overnight (day 1)
Episodes of apnea and/or hypopnea scored during the course of sleep study
1 secondary outcome
Arterial Oxygen Saturation (SaO2)
Time frame: Overnight (day 1)
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 31 May 2023.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Lee Shangold, MD principal investigator
ENT & Allergy Associates, LLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Upper Airway Stimulation Device in people with Obstructive Sleep Apnea and OSA, run by Somnial Inc 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 6 inclusion and 4 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 31 May 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 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?
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?
Apnea Hypopnea Index (time frame: Overnight (day 1)). 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 31 May 2023.