Status:
UNKNOWN
Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
Lead Sponsor:
Norton Healthcare
Collaborating Sponsors:
Delta Dental Foundation
Conditions:
Snoring
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
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, ...
Detailed Description
This study proposed to determine if the use of an oral device which causes forward positioning of the tongue will decrease the intensity and frequency of snoring as measured by the SnoreLab phone app,...
Eligibility Criteria
Inclusion
- . 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-
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04900285
Start Date
June 1 2021
End Date
December 31 2023
Last Update
April 6 2022
Active Locations (1)
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1
Norton Clinical Research Group
Louisville, Kentucky, United States, 40218