Snoring Clinical Trial
Official title:
Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. . Able to provide informed consent 2. Age 18 or older 3. Self-report of snoring problems 4. 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: 1. Missing teeth. 2. Respiratory disorders requiring treatment including asthma, COPD 3. Poor dental health including gum disease or loose teeth 4. Dental implants placed within the last three months 5. Temporomandibular joint dysfunction 6. Presence of mouth or jaw pain 7. Bruxism (teeth grinding) 8. Full dentures 9. No bed partner 10. Braces 11. Diagnosed with Obstructive or Central Sleep Apnea, Sleep Apnea 12. Uncontrolled RLS 13. Ongoing or prior use of a dental device 14. Noise in bedroom i.e., fan, bed partner snoring 15. Other medical or sleep issues which will interfere with the device per PI discretion 16. Does not have a smart phone 17. Other medical condition that PI believes will make the patient ineligible for participation |
Country | Name | City | State |
---|---|---|---|
United States | Norton Clinical Research Group | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Norton Healthcare | Delta Dental Foundation |
United States,
Cartwright RD. Alcohol and NREM parasomnias: evidence versus opinions in the international classification of sleep disorders, 3rd edition. J Clin Sleep Med. 2014 Sep 15;10(9):1039-40. doi: 10.5664/jcsm.4050. — View Citation
Cooke ME, Battagel JM. A thermoplastic mandibular advancement device for the management of non-apnoeic snoring: a randomized controlled trial. Eur J Orthod. 2006 Aug;28(4):327-38. Epub 2006 Jun 13. — View Citation
Deeb R, Judge P, Peterson E, Lin JC, Yaremchuk K. Snoring and carotid artery intima-media thickness. Laryngoscope. 2014 Jun;124(6):1486-91. doi: 10.1002/lary.24527. Epub 2014 Jan 28. — View Citation
Gliklich RE, Wang PC. Validation of the snore outcomes survey for patients with sleep-disordered breathing. Arch Otolaryngol Head Neck Surg. 2002 Jul;128(7):819-24. — View Citation
Johnston CD, Gleadhill IC, Cinnamond MJ, Peden WM. Oral appliances for the management of severe snoring: a randomized controlled trial. Eur J Orthod. 2001 Apr;23(2):127-34. — View Citation
Meira e Cruz M., Cardiovascular Center of University of Lisbon, Lisbon School of Medicine, Lisbon, Portugal; Email: mcruz@medicina.ulisboa.pt
Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome) | To determine if use of a device to position the tongue forward will decrease the intensity of snoring. | Daily up to 15 days | |
Primary | Frequency of Snoring (Snore Lab App, app records snoring through the night) | To determine if use of a device to position the tongue forward will decrease the frequency of snoring. | Daily up to 15 days | |
Secondary | Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item) | Evaluate the level of snoring of the subject by bed partner using approved questionnaire | Day 5 (end of no device use) | |
Secondary | Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item) | Evaluate the level of snoring of the subject by bed partner using approved questionnaire | Day 10 (end of lower device use) | |
Secondary | Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item) | Evaluate the level of snoring of the subject by bed partner using approved questionnaire | Day 15 (end of lower and upper device use) | |
Secondary | Device Tolerance and Comfort (Tolerance Form) | Subject Evaluation of tolerance and comfort of the oral device by questionnaire | Day 5 (end of no device use) | |
Secondary | Device Tolerance and Comfort (Tolerance Form) | Subject Evaluation of tolerance and comfort of the oral device by questionnaire | Day 10 (end of lower device use) | |
Secondary | Device Tolerance and Comfort (Tolerance Form) | Subject Evaluation of tolerance and comfort of the oral device by questionnaire | Day 15 (end of lower and upper device use) | |
Secondary | Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) ) | Evaluate the quality of sleep of subject by bed partner by questionnaire | Day 5 (end of no device use) | |
Secondary | Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) | Evaluate the quality of sleep of subject by bed partner by questionnaire | Day 10 (end of lower device use) | |
Secondary | Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) | Evaluate the quality of sleep of subject by bed partner by questionnaire | Day 15 (end of lower and upper device use) |
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