Neurostimulation for Sleep Disordered Breathing (SDB) | NCT07243405

Studies
Neurostimulation for Sleep Disordered Breathing (SDB)

NCT07243405

Sponsor

Lunair Medical

Status

Recruiting

Last Update Posted

Nov 21, 2025Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Sleep Disordered Breathing (SDB)
Sleep Apnea

Interventions

Neuro stimulator implant

Countries

Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2025Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Nov 17, 2025

First Posted Date

Nov 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2025

Last Update Posted Date

Nov 21, 2025Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Label	Type	Description	Intervention Names
Alpha Lunair System implanted subjects	Experimental		Device: Neuro stimulator implant

Name	Type	Description	Arm Group Labels	Other Names
Neuro stimulator implant	Device	Neuro stimulator for treating sleep disordered breathing	Alpha Lunair System implanted subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Endpoint - assessment of procedure or device related adverse events	Incidence of adverse events (AEs) related to the Lunair system or procedure	enrollment to 12 months post-implant

Secondary Outcomes

Measure	Description	Time Frame
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	six month, 12 month and 24 month post implant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic