Status:
COMPLETED
Mechanisms of Upper Airway Obstruction
Lead Sponsor:
University of Pennsylvania
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep. The investigators' major hypothesis is that specific tong...
Detailed Description
Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction due to inadequate muscle tone during sleep leading to nocturnal hypercapnia, repeated oxyhemoglobin desaturations a...
Eligibility Criteria
Inclusion
- Adults (≥ 22yrs)
- Implanted with the MRI-conditional Inspire hypoglossal nerve stimulator (Model 3028 or later)
- Compliant with Inspire therapy (\> 20 hours/week over 2+ weeks) as a standalone treatment for sleep-disordered breathing
- Inspire remote model 2500 or later
Exclusion
- MRI contraindications (claustrophobia, ferromagnetic implants, foreign bodies, etc)
- Inspire Implant Model 3024
- Inspire Remote Model 3032
- Patients who have fallen asleep while driving resulting in an accident or "near miss" accident within 1 year prior to device implantation
- Inability to sleep in the supine position (by self-report)
- History of severe difficulty initiating or maintaining sleep in the laboratory
- Pregnant women
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2024
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04322097
Start Date
June 3 2020
End Date
May 10 2024
Last Update
April 23 2025
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104