Obstructive Sleep ApneaEarly Phase 1Trans-Q DISENCT06762873
Assessment of OSA in Latin American and Response to Neuromod Therapy
A Early Phase 1 study testing Drug Induced Sleep Endoscopy with PNS in people with Obstructive Sleep Apnea, run by Lunair Medical at 1 site in Paraguay.
Trial summary
The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate/severe obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA. 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?
- Drug Induced Sleep Endoscopy with PNS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteParaguay
- Study dates
- 21 Nov 2024to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Subject is aged ≥ 18 years old
- Subject is willing and able to provide informed consent
- Subject is geographically stable
- Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and/or behavioral treatments)
- Subject has an Apnea-Hypopnea Index (AHI) score ≥15 < 100 events per hour on Screening PSGs (under AASM 4%) based on in-lab polysomnography studies
Who cannot join
- Subject is currently implanted with another active implantable device.
- Subject is actively enrolled in another premarket investigational study (medical device or drug) unless approved by Sponsor in writing.
- Subject is considered vulnerable such as incarcerated or cognitively impaired.
- Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that in the opinion of the investigator may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
- Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study ((e.g. uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD, major depression, Parkinson's disease, epilepsy)
- Subject has previous upper respiratory tract (URT) surgery (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.
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- Subject has a need for chronic supplemental oxygen therapy for any reason or a PaO2 <70 mm Hg
- Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness and/or overnight PSG Study outcomes (e.g. Narcolepsy with cataplexy, idiopathic hypersomnolence, insomnia, REM sleep behavior disorder, or sleep movement disorders, such as restless leg syndrome or periodic limb movement, producing sleep disturbances unrelated to OSA.)
- Subject has severe chronic kidney disease (GFR < 30)
- Subject has currently excessive use of alcohol, tobacco, caffeine, or recreational drugs.
- Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.
- Subject has a BMI > 40 kg/m2
- Subject has an active systemic infection
- If female, subject is pregnant at the time of enrollment or planning to become pregnant during the study time period (must have a negative serum or urine pregnancy test within 14 days prior to enrollment)
- Subject has a tonsil size 3 or 4 based on the tonsil grading system
- Subject has documented history of Phrenic nerve palsy or asymmetry of the diaphragm
- Subject has any trauma to the upper airway that interferes with limited tongue movement or inability to move the tongue, tongue dysfunction, atrophy, hypertrophy, fasciculation, or problems swallowing or speaking
- Subject has severe mandibular deficiency/retrognathia or syndromic craniofacial abnormalities.
- Subject has previous surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
- Subject has an oxygen saturation (SaO2) >10% falls index > 15 events per hour on Screening PSGs
- Subject has >25% central apnea events as a proportion of the sum of apnea and hypopnea events per hour on Screening PSGs (up to 3 patients with CAI+MAI ≥ 25% may be included)
- Subject has sleep Efficiency < 80%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paraguay1 site, 1 recruiting
- Recruiting
Sanatorio Americano
Asunción
Medical Doctor, 866-675-4430, andreas@lunairmedical.com
About this study
Official title: Assessment of Obstructive Sleep Apnea in the Latin American Population and Response to Neuromodulation Therapy to Treat Obstructive Sleep Apnea
The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate/severe obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Drug Induced Sleep Endoscopy with PNS
- 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.
Drug Induced Sleep Endoscopy with PNSDiagnostic test
Enrolled subjects will complete an overnight PSG and then undergo a DISE procedure with a 30-minute research period.
| Study group | Role | What they receive |
|---|---|---|
| Trans-Q DISE treated subjects | Experimental | Not described Receives: Diagnostic Test: Drug Induced Sleep Endoscopy with PNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand the difference in response compared to prior U.S. based studies to the response in Latin America.
Reviewing phrenic nerve stimulation response to literature of US based population
Measured: enrollment to study exit, usually within 3 weeks of screening
Use VOTE scoring to characterize the type of upper airway collapse as assessed via DISE.
Upper Airway will be characterized using VOTE scoring as assessed by a qualified, trained Independent Reviewer.
Measured: enrollment to study exit, usually within 3 weeks of screening
Use VOTE scoring and airway opening measurements to characterize the effect of Phrenic Nerve Stimulation and if it is a viable and effective treatment of OSA and correlation to phenotype.
In combination with VOTE scoring and airway opening measurements, the effects of phrenic nerve stimulation will be compared across treated patient population.
Measured: enrollment to study exit, usually within 3 weeks of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start21 Nov 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lunair Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762873
- Sponsor's protocol ID
- 10081
- Acronym
- Trans-Q DISE
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Obstructive Sleep Apnea in the Latin American Population and Response to Neuromodulation Therapy to Treat Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06762873
- Acronym / sponsor ID
- Trans-Q DISE / 10081
- Conditions
- Obstructive Sleep Apnea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lunair MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jan 2025 (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.
The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate/severe obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans-Q DISE treated subjects | Experimental | Diagnostic Test: Drug Induced Sleep Endoscopy with PNS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is aged ≥ 18 years old
- Subject is willing and able to provide informed consent
- Subject is geographically stable
- Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and/or behavioral treatments)
- Subject has an Apnea-Hypopnea Index (AHI) score ≥15 < 100 events per hour on Screening PSGs (under AASM 4%) based on in-lab polysomnography studies
Key exclusion criteria (22 listed)
- Subject is currently implanted with another active implantable device.
- Subject is actively enrolled in another premarket investigational study (medical device or drug) unless approved by Sponsor in writing.
- Subject is considered vulnerable such as incarcerated or cognitively impaired.
- Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that in the opinion of the investigator may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
- Any reason for which, in the judgment of the investigator, the subject is considered to be a poor study candidate, which may include, but is not limited to: any uncontrolled neurological, medical, social, or psychological problems that could complicate the required procedures and evaluations of the study ((e.g. uncontrolled hypertension, unstable angina, uncompensated heart failure or COPD, major depression, Parkinson's disease, epilepsy)
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 |
|---|---|---|
| Drug Induced Sleep Endoscopy with PNSEnrolled subjects will complete an overnight PSG and then undergo a DISE procedure with a 30-minute research period. | Diagnostic test | Trans-Q DISE treated subjects |
Primary outcome
Understand the difference in response compared to prior U.S. based studies to the response in Latin America.
Time frame: enrollment to study exit, usually within 3 weeks of screening
Reviewing phrenic nerve stimulation response to literature of US based population
Use VOTE scoring to characterize the type of upper airway collapse as assessed via DISE.
Time frame: enrollment to study exit, usually within 3 weeks of screening
Upper Airway will be characterized using VOTE scoring as assessed by a qualified, trained Independent Reviewer.
Use VOTE scoring and airway opening measurements to characterize the effect of Phrenic Nerve Stimulation and if it is a viable and effective treatment of OSA and correlation to phenotype.
Time frame: enrollment to study exit, usually within 3 weeks of screening
In combination with VOTE scoring and airway opening measurements, the effects of phrenic nerve stimulation will be compared across treated patient population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Drug Induced Sleep Endoscopy with PNS in people with Obstructive Sleep Apnea, run by Lunair Medical at 1 site in Paraguay.
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 22 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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 Paraguay. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Director of Clinical Operations (866-675-4430, andreas@lunairmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand the difference in response compared to prior U.S. based studies to the response in Latin America. (time frame: enrollment to study exit, usually within 3 weeks of screening). The study lists 3 primary outcomes in all. 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 3 Sep 2025.