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NCT05429983 · ClinicalTrials.gov registry record
Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics
A clinical trial of Sleep Apnea, Obstructive, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT05429983: Recruiting study of Sleep Apnea, Obstructive, sponsored by Johns Hopkins University.
NCT05429983 is a study of Sleep Apnea, Obstructive that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 60 participants, below the 261-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05429983, a study of Sleep Apnea, Obstructive, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. Inspire™ is an FDA-approved hypoglossal nerve stimulation device (HGNS) used in select patients with OSA who are intolerant of CPAP. The device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. Despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to HGNS and remain at risk for complications from untreated OSA. The current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to HGNS therapy. Drug induced sleep endoscopy (DISE) is a prerequisite for HGNS treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. The amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of OSA with HGNS. As a result, CPAP titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of DISE to select parties for HGNS at multiple institutions. Nevertheless, changes in upper airway collapsibility in response HGNS may differ significantly between patients. This stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of DISE predicts successful treatment with HGNS as defined by a 50% reduction on apnea-hypopnea index (AHI) and an on-treatment AHI \<20.
Conditions Studied
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2028-11-29 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05429983
The ClinicalTrials.gov registry entry for NCT05429983 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (77% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 0 interventions.
NCT05429983 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05429983 about?
NCT05429983 is a clinical study titled "Predicting Outcomes in Hypoglossal Nerve Stimulation Therapy With Stimulated Upper Airway Mechanics". Obstructive sleep apnea (OSA) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. Continuous positive airway pressure (CPAP) is highly efficacious but high rates of non-adherence to CPAP leaves large number of OSA patients at risk for cardiometabolic sequelae. In...
What is the current status of trial NCT05429983?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2022-11-29. Estimated completion is 2028-11-29.
What conditions does trial NCT05429983 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive.
Who is sponsoring clinical trial NCT05429983?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05429983 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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