Obstructive Sleep Apnea study: No HGNS therapy
Official title Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
ClinicalTrials.gov ID: NCT06720545
What this study is testing
- What it's testing
- The study will look at cardiovascular and metabolic measures to see if stopping the therapy affects the risk of health problems linked to sleep apnea.
- Who it's for
- Adults who have obstructive sleep apnea and are receiving hypoglossal nerve stimulation.
- What's involved
- Participants will discontinue the implanted nerve stimulation and undergo tests to measure heart and metabolism changes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- English-speaking adults (18+ years) who have met surgical how well it works criteria with HGNS, as defined by at least a 50% reduction in...
- Have been using HGNS therapy for at least 3 months and used HGNS for \>20 hours/week during the past 4 weeks
- Were not using any OSA therapy for at least one month prior to HGNS activation or have had a one-month period of untreated OSA after HGNS activation
You likely can't join if
- Chronic use of opiate medications, illicit drugs, or alcohol dependency
- Women who are pregnant or planning to become pregnant
- Shift workers, heavy machinery operators, or commercial drivers
- History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score \>16 at time of screening or prior to HGNS), motor vehicle accidents...
- Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease
- Inability to provide informed consent
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.