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Behavioural Intervention
Oral Appliance for Snoring
N/A
Waitlist Available
Led By David Winslow, MD
Research Sponsored by Norton Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily up to 15 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how well a lower and upper dental device reduces snoring by moving the genioglossus muscle forward.
Who is the study for?
This trial is for adults over 18 who snore and have a partner able to report on their snoring. Participants must be able to consent, not have used a dental device before, and should have good dental health without loose teeth or gum disease. They need a smartphone but can't join if they have respiratory disorders, jaw pain, grind their teeth, or certain other medical conditions.
What is being tested?
The study is testing how well people can tolerate wearing an oral device while sleeping and if it helps reduce snoring. The device works by moving the tongue forward in the mouth using attachments that keep it in place.
What are the potential side effects?
Potential side effects may include discomfort in the mouth or jaw due to the new position of the tongue and muscle attachment. There might also be increased saliva production or difficulty adapting to sleeping with the device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily up to 15 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily up to 15 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of Snoring (Snore Lab App, app records snoring through the night)
Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome)
Secondary study objectives
Device Tolerance and Comfort (Tolerance Form)
Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dental Device ArmExperimental Treatment1 Intervention
Subjects in this single arm study serve as their own control by recording snoring on the SnoreLab device for five days and completing the Snore Outcomes survey. After five nights with now device, the lower dental device is used for five nights and snoring is recorded in the SnoreLab app. At the end of the five nights the subjects complete the Comfort and Difficulties Form and the bed partner completes the Snore Outcomes Survey. If the lower device was tolerated well, the process is repeated with the upper dental device used with the lower device.
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Who is running the clinical trial?
Delta Dental FoundationOTHER
7 Previous Clinical Trials
1,405 Total Patients Enrolled
Norton HealthcareLead Sponsor
16 Previous Clinical Trials
2,831 Total Patients Enrolled
David Winslow, MDPrincipal InvestigatorNorton Healthcare
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Currently using or have used a dental device in the pastYou have reported having trouble with snoring.You have gum disease or loose teeth.You do not have a bed partner.You have some teeth that are not there.You have lung conditions like asthma or COPD that need treatment.You have problems with your jaw joint.You have pain in your mouth or jaw.You grind your teeth.You have gotten dental implants in the last three months.You have full dentures.You have braces on your teeth.You have restless legs syndrome that is not being effectively managed.You have been diagnosed with obstructive or central sleep apnea.You are bothered by noises in your bedroom, such as a fan or a snoring bed partner.
Research Study Groups:
This trial has the following groups:- Group 1: Dental Device Arm
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.