Sleep Disordered Breathing (SDB)ECLIPSE 1NCT06883617
Neurostimulation for Sleep Disordered Breathing
A study testing Neuro stimulator Implant in people with Sleep Disordered Breathing (SDB) and Sleep Apnea, run by Lunair Medical at 1 site in Paraguay.
Trial summary
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing (SDB), Sleep Apnea
- What is being tested?
- Neuro stimulator Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteParaguay
- Study dates
- 13 Jan 2025to 15 Dec 2027
- Phase
- Interventional
- 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 does not tolerate, not compliant to or have access to alternative Sleep Disordered Breathing treatments
- Subject has moderate to severe sleep disordered breathing as diagnosed by PSG
Who cannot join
- Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that 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
- Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.
- Subject has a need for chronic supplemental oxygen therapy for any reason
- Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness
- Subject has severe chronic kidney disease
Show all 17Show fewer
- Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study.
- Subject conducts work or regular activities requiring vigilance
- Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.
- Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices
- Subject has an active systemic infection at time of implant.
- Subject has clinical evidence of immunodeficiency.
- Any condition likely to require future MRI or diathermy
- Subject is pregnant
- Subject has a severe nasal obstruction that could restrict airflow
- Subject has any trauma to the upper airway
- Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
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, Paraguay
Santos, MD, 866-675-4430, andreas@lunairmedical.com
About this study
Official title: The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Conditions
- Sleep Disordered Breathing (SDB), Sleep Apnea
- Being tested
- Neuro stimulator Implant
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro stimulator ImplantDevice
Neuro Stimulator for treating sleep disordered breathing
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lunair System implanted subjects | Experimental | Not described Receives: Device: Neuro stimulator Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint - assessment of procedure or device related adverse events
Incidence of adverse events (AEs) related to the Lunair system or procedure
Measured: enrollment to 12 months post-implant
Secondary outcomes (1)
Improvement in sleep disordered breathing per sleep study
Improvement in sleep disordered breathing at 6, 12 and 24 months post implant during an attended sleep study
Measured: six months, 12 month and 24 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start13 Jan 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered Breathing (SDB)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First-in-Human, prospective, multicenter, single arm, feasibility clinical study
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT06883617
- Sponsor's protocol ID
- 10050
- Acronym
- ECLIPSE 1
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 20 Mar 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT06883617
- Acronym / sponsor ID
- ECLIPSE 1 / 10050
- Conditions
- Sleep Disordered Breathing (SDB), Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Lunair MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 19 Mar 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.
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First-in-Human, prospective, multicenter, single arm, feasibility clinical study
| Arm | Type | Receives |
|---|---|---|
| Alpha Lunair System implanted subjects | Experimental | Device: Neuro stimulator Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject does not tolerate, not compliant to or have access to alternative Sleep Disordered Breathing treatments
- Subject has moderate to severe sleep disordered breathing as diagnosed by PSG
Key exclusion criteria (17 listed)
- Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that 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
- Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.
- Subject has a need for chronic supplemental oxygen therapy for any reason
- Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness
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 |
|---|---|---|
| Neuro stimulator ImplantNeuro Stimulator for treating sleep disordered breathing | Device | Alpha Lunair System implanted subjects |
Primary outcome
Safety Endpoint - assessment of procedure or device related adverse events
Time frame: enrollment to 12 months post-implant
Incidence of adverse events (AEs) related to the Lunair system or procedure
1 secondary outcome
Improvement in sleep disordered breathing per sleep study
Time frame: six months, 12 month and 24 months post implant
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 20 Mar 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 study testing Neuro stimulator Implant in people with Sleep Disordered Breathing (SDB) and 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 2 inclusion and 17 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 20 Mar 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.
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 (1-866-675-4430, andreas@lunairmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint - assessment of procedure or device related adverse events (time frame: enrollment to 12 months post-implant). 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 20 Mar 2025.