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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07049744




Registration number
NCT07049744
Ethics application status
Date submitted
25/06/2025
Date registered
3/07/2025
Date last updated
3/07/2025

Titles & IDs
Public title
Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
Scientific title
Bilateral Hypoglossal Nerve Stimulation With the XII Medical HGNS System for the Treatment of Adult Obstructive Sleep Apnea Pilot Study
Secondary ID [1] 0 0
XII-002
Universal Trial Number (UTN)
Trial acronym
BEAT OSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XII Medical HGNS System

Experimental: XII Medical HGNS System - Participants receiving HGNS using the XII Medical System


Treatment: Devices: XII Medical HGNS System
XII Medical HGNS System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of the XII Medical HGNS System
Timepoint [1] 0 0
Six months post-implantation
Secondary outcome [1] 0 0
Performance of the XII Medical HGNS System
Timepoint [1] 0 0
Six months post-implantation
Secondary outcome [2] 0 0
Performance of the XII Medical HGNS System
Timepoint [2] 0 0
Six months post-implantation

Eligibility
Key inclusion criteria
* Body Mass Index (BMI) = 32 kg/m2
* AHI of 15-50 events/hour
* Central + mixed apnea index = 25%
* Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or breast-feeding.
* Significant upper airway anatomic abnormalities
* Hypoglossal nerve weakness
* Central sleep apnoea condition
* Significant positionally-dependent OSA.
* Complete concentric patterns of soft palate collapse on DISE
* Inadequately treated non-OSA sleep disorder(s).
* Significant co-morbidities or prior surgeries that contra-indicate a surgical procedure or general anesthesia
* Taking medications that in the opinion of the investigator may alter consciousness, the pattern of respiration, or sleep architecture
* Participants on a GLP-1

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2029
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
XII Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Professor Stuart MacKay FRACS
Address 0 0
Country 0 0
Phone 0 0
+61 2 4226 1055
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07049744