Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring

Status unconfirmed · Not applicable

Conditions studied: Snoring

In brief

This research study proposes to determine how well tolerated and effective lower and upper oral dental devices are at reducing snoring. The device is designed to move the genioglossus muscle forward, with interior attachment to maintain forward placement of of he tongue on the bottom of the mouth.

Key facts

Study ID

NCT04900285

Run by

Norton Healthcare

People needed

30

Starts

2021-06-01

Expected to finish

2023-12-31

Last updated by the study team

2022-04-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• . Able to provide informed consent
• Age 18 or older
• Self-report of snoring problems
• Has a bed partner that is willing and able to consent as well as answer questions related to partner's snoring both with and without oral device-

You may not qualify if…

• Missing teeth.
• Respiratory disorders requiring treatment including asthma, COPD
• Poor dental health including gum disease or loose teeth
• Dental implants placed within the last three months
• Temporomandibular joint dysfunction
• Presence of mouth or jaw pain
• Bruxism (teeth grinding)
• Full dentures
• No bed partner
• Braces
• Diagnosed with Obstructive or Central Sleep Apnea, Sleep Apnea
• Uncontrolled RLS
• Ongoing or prior use of a dental device
• Noise in bedroom i.e., fan, bed partner snoring
• Other medical or sleep issues which will interfere with the device per PI discretion
• Does not have a smart phone
• Other medical condition that PI believes will make the patient ineligible for participation

Where it is running

• Norton Clinical Research Group — Louisville, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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