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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily up to 15 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Delta Dental FoundationOTHER

7 Previous Clinical Trials

1,405 Total Patients Enrolled

Norton HealthcareLead Sponsor

15 Previous Clinical Trials

2,868 Total Patients Enrolled

David Winslow, MDPrincipal InvestigatorNorton Healthcare

Media Library

Delta Dental Oral Device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04900285 — N/A

Snoring Research Study Groups: Dental Device Arm

Snoring Clinical Trial 2023: Delta Dental Oral Device Highlights & Side Effects. Trial Name: NCT04900285 — N/A

Delta Dental Oral Device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04900285 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is the clinical trial trying to accomplish?

"The primary endpoint of this trial, assessed daily up to 15 days, is the Frequency of Snoring (Snore Lab App). Furthermore, Device Tolerance and Comfort (Tolerance Form) will be determined via Subject Evaluation questionnaire; Quality of Sleep Assessment (Snore Outcomes Survey), by both subject and bed partner responses on a scale that varies per item."

Answered by AI

Is it possible to join the experiment at this time?

"This investigation seeks to enroll 30 participants aged 18 or older who experience snoring. Furthermore, applicants must have a bed partner that is willing and able to consent for the study as well as answer inquiries about their partner's snoring with and without an oral device."

Answered by AI

Are there any vacancies available to join this clinical trial?

"Affirmative. Information located on clinicaltrials.gov demonstrates that this clinical investigation is recruiting participants right now. It was first posted on June 1st 2021 and has recently been updated to reflect new information on April 5th 2022. The study requires 30 people to join from one specified location."

Answered by AI

Is the age limit for entry into this research endeavor restricted to those under seventy?

"The age range of participants eligible for this trial is 18-99."

Answered by AI

How many people have registered to participate in this clinical experiment?

"Affirmative. Per the clinicaltrials.gov website, this research project has been actively recruiting from June 1st 2021 and is in need of 30 participants at a single medical facility as of April 5th 2022."

Answered by AI

Recent research and studies

Archives of Otolaryngology–Head & Neck SurgeryJournal

Validation of the Snore Outcomes Survey for Patients with Sleep-disordered Breathing

Gliklich, Richard E., and Pa-Chun Wang. 2002. “Validation of the Snore Outcomes Survey for Patients with Sleep-disordered Breathing”. Archives of Otolaryngology–head & Neck Surgery. American Medical Association (AMA). doi:10.1001/archotol.128.7.819.

The European Journal of OrthodonticsJournal

Oral Appliances for the Management of Severe Snoring: A Randomized Controlled Trial

Johnston, C. D.. 2001. “Oral Appliances for the Management of Severe Snoring: A Randomized Controlled Trial”. The European Journal of Orthodontics. Oxford University Press (OUP). doi:10.1093/ejo/23.2.127.

Journal of Clinical Sleep MedicineJournal

Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015

Ramar, Kannan, Leslie C. Dort, Sheri G. Katz, Christopher J. Lettieri, Christopher G. Harrod, Sherene M. Thomas, and Ronald D. Chervin. 2015. “Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015”. Journal of Clinical Sleep Medicine. American Academy of Sleep Medicine (AASM). doi:10.5664/jcsm.4858.

The LaryngoscopeJournal