Neurostimulation for Sleep Disordered Breathing (SDB) (ECLIPSE 2)

November 17, 2025 updated by: Lunair Medical

The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing

This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Panama
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, Panama
        • Recruiting
        • Hospital Paitilla
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 judgement 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
  • 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 the time of implant
  • Subject has clinical evidence of immunodeficiency
  • Any condition likely to require future MRI or diathermy
  • Subject is pregnant
  • Subject has 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alpha Lunair System implanted subjects
Device: Neuro stimulator implant
Neuro stimulator for treating sleep disordered breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
enrollment to 12 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in sleep disordered breathing per sleep study
Time Frame: six month, 12 month and 24 month post implant
Improvement in sleep disordered breathing at 6,12 and 24 months post implant during an attended sleep study
six month, 12 month and 24 month post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lunair Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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