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New treatment option for Obstructive Sleep Apnea (OSA)
Official title Hypoglossal Nerve Stimulation for the Treatment of Adult Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT07049744
What this study is testing
- What it's testing
- The goal of this interventional study is to assess the safety and performance of the XII Medical Hypoglossal Nerve Stimulation (HGNS) System in people who have moderate to severe Obstructive Sleep Apnea (OSA). Participation in this study involves being implanted with a Neurostimulator which provides electrical stimulation of the hypoglossal nerve (HGN).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canberra, Australian Capital Territory, Australia
- Sydney, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Brisbane, Queensland, Australia
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canberra, Australian Capital Territory, Australia; Sydney, New South Wales, Australia; Wollongong, New South Wales, Australia; Brisbane, Queensland, Australia; Perth, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.