Assessment of OSA in Latin American and Response to Neuromod Therapy

NCT ID: NCT06762873

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-21
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Trans-Q DISE treated subjects

Group Type: EXPERIMENTAL

Drug Induced Sleep Endoscopy with PNS

Intervention Type: DIAGNOSTIC_TEST

Enrolled subjects will complete an overnight PSG and then undergo a DISE procedure with a 30-minute research period.

Interventions

Drug Induced Sleep Endoscopy with PNS

Enrolled subjects will complete an overnight PSG and then undergo a DISE procedure with a 30-minute research period.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Subject is aged ≥ 18 years old

2. Subject is willing and able to provide informed consent

3. Subject is geographically stable

4. Subject does not have access to alternative Sleep Disordered Breathing treatments (e.g. oral appliances, and/or behavioral treatments)

5. 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

Exclusion Criteria

1. Subject is currently implanted with another active implantable device.

2. Subject is actively enrolled in another premarket investigational study (medical device or drug) unless approved by Sponsor in writing.

3. Subject is considered vulnerable such as incarcerated or cognitively impaired.

4. 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.

5. 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)

6. Subject has previous upper respiratory tract (URT) surgery (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.

7. Subject has a need for chronic supplemental oxygen therapy for any reason or a PaO2 <70 mm Hg

8. 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.)

9. Subject has severe chronic kidney disease (GFR < 30)

10. Subject has currently excessive use of alcohol, tobacco, caffeine, or recreational drugs.

11. Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study.

12. Subject has a BMI > 40 kg/m2

13. Subject has an active systemic infection

14. 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)

15. Subject has a tonsil size 3 or 4 based on the tonsil grading system

16. Subject has documented history of Phrenic nerve palsy or asymmetry of the diaphragm

17. 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

18. Subject has severe mandibular deficiency/retrognathia or syndromic craniofacial abnormalities.

19. Subject has previous surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.

20. Subject has an oxygen saturation (SaO2) >10% falls index > 15 events per hour on Screening PSGs

21. 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)

22. Subject has sleep Efficiency < 80%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lunair Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sanatorio Americano

Asunción, , Paraguay

Site Status: RECRUITING

Countries

Paraguay

Central Contacts

Andrea Director of Clinical Operations

Role: CONTACT

andreas@lunairmedical.com

866-675-4430

Facility Contacts

Medical Doctor

Role: primary

andreas@lunairmedical.com

866-675-4430

Other Identifiers

10081

Identifier Type: -

Identifier Source: org_study_id