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Airway Opening Techniques for Obstructive Sleep Apnea (DISE-CAD Trial)
N/A
Recruiting
Led By Raj C Dedhia, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (≥ 22yrs)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 months of enrollment
Awards & highlights
DISE-CAD Trial Summary
This trial is looking at how different tongue muscles help keep the airway open during sleep, to see which ones are most important.
Who is the study for?
This trial is for adults over 22 with obstructive sleep apnea who have an MRI-safe Inspire hypoglossal nerve stimulator and use it more than 20 hours a week. It's not for those with MRI contraindications, certain Inspire models, a recent sleep-related driving incident, trouble sleeping on their back or in labs, or pregnant women.Check my eligibility
What is being tested?
The study tests how specific tongue muscles help keep the airway open during sleep using treatments like lingual muscle stimulation and tongue exercises. Techniques include MRIs to view muscles and overnight studies (PSG) to monitor sleep and breathing.See study design
What are the potential side effects?
Possible side effects may include discomfort from the tongue exercises or muscle stimulation, anxiety or claustrophobia from MRI procedures, and potential sleep disturbances during overnight monitoring.
DISE-CAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
DISE-CAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 3 months of enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 months of enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amax
Pharyngeal compliance
Segmental Airway Resistances
+1 moreSecondary outcome measures
Digital Morphometrics
Tongue Force
DISE-CAD Trial Design
1Treatment groups
Experimental Treatment
Group I: Lingual Muscle Stimulation PatientsExperimental Treatment7 Interventions
DISE
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,109 Total Patients Enrolled
Raj C Dedhia, MDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had significant trouble falling or staying asleep during a sleep study.I cannot sleep on my back.I have used Inspire therapy for my sleep disorder for over 20 hours a week.You need to have Inspire remote model 2500 or a newer version.I am 22 years old or older.You have a specific type of hypoglossal nerve stimulator implanted that is safe for MRI scans.You cannot have an MRI due to claustrophobia, metal implants, or other objects in your body that can't go in the MRI machine.You have an Inspire Implant Model 3024.This criterion does not appear to be related to clinical trial exclusion criteria. Can you provide more context or clarify the request?You have fallen asleep while driving and had an accident or almost had an accident within the year before getting the device implanted.
Research Study Groups:
This trial has the following groups:- Group 1: Lingual Muscle Stimulation Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of participants involved in this research?
"Affirmative. According to clinicaltrials.gov, this research is currently recruiting test subjects. This study was initially published on June 3rd 2020 and edited for the last time on November 14th 2022 with a target of 100 participants from one site."
Answered by AI
Are any new participants being enrolled in this research at the moment?
"Affirmative. Clinicaltrials.gov attests to this trial's active recruitment of participants, which began on June 3rd 2020 and was last revised November 14th 2022. The researchers are looking for 100 individuals across a single site."
Answered by AI
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