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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    30
  • sponsor
    Norton Healthcare
Updated on 27 April 2022
Accepts healthy volunteers

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, with interior attachment to maintain forward placement of of he tongue on the bottom of the mouth.

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, evaluate the level of snoring as measured by the bed partner, evaluate tolerance and comfort of the device and evaluate the quality of sleep of the subject by the bed partner.

Subjects will sleep at home using the SnoreLab app to record snoring for five nights and fill out the Snore Outcomes Survey. They will then utilize the lower dental device for five nights recording their snoring. At the end of the five nights of using the lower dental device, the subjects will fill out the comfort and difficulties form with the bed partner completing the Snore Outcomes Survey. If the lower device is tolerated, the process is repeated with the upper device added to the lower device.

Details
Condition Snoring
Treatment Delta Dental Oral Device
Clinical Study IdentifierNCT04900285
SponsorNorton Healthcare
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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