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

Primary Purpose

Snoring

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Delta Dental Oral Device

About this trial

This is an interventional prevention trial for Snoring

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Norton Clinical Research GroupRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dental Device Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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

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

Device Tolerance and Comfort (Tolerance Form)

Subject Evaluation of tolerance and comfort of the oral device by questionnaire

Device Tolerance and Comfort (Tolerance Form)

Subject Evaluation of tolerance and comfort of the oral device by questionnaire

Device Tolerance and Comfort (Tolerance Form)

Subject Evaluation of tolerance and comfort of the oral device by questionnaire

Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) )

Evaluate the quality of sleep of subject by bed partner by questionnaire

Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)

Evaluate the quality of sleep of subject by bed partner by questionnaire

Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)

Evaluate the quality of sleep of subject by bed partner by questionnaire

Full Information

NCT ID

NCT04900285

First Posted

May 13, 2021

Last Updated

April 5, 2022

Sponsor

Norton Healthcare

Collaborators

Delta Dental Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04900285

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Norton Healthcare

Collaborators

Delta Dental Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Snoring

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Subject serve as their own control sleeping without the device for five days and recording snoring on the SnoreLab app and filling out the Snore Outcomes Survey. The lower dental device is used for five days while recording snoring. The subject will then complete the Comfort and Difficulties Form and the bed partner completes the Snore Outcomes Survey. The process is repeated with the upper device for those who tolerate the lower device. use.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dental Device Arm

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Delta Dental Oral Device

Intervention Description

The oral device is designed to move the genioglossus forward, with interior attachments to maintain the placement of the tongue on the floor of the mouth forward. In addition, bite plates made of the Ethylene-vinyl acetate (EVA) plastic were fabricated and embedded with the mouthpiece to encourage subjects to bite down and push the tongue under the interior lower attachment. The upper plate is made of the same material and slightly opens the bite to improve oral air flow further. The primary component of the mouthpiece is fabricated with Vistamaxx material, which is semi-crystalline 2mm co-polymer that can be molded by the user with Nurse assistance to provide a custom fit. The subject will be fitted by moistening and heating in a microwave. Tthe research staff member will assist to ensure proper fit with both the lower and upper dental devices. The subject then completes the data collection portion regarding using the SnoreLab app and survey completion as previously described.

Primary Outcome Measure Information:

Title

Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome)

Description

To determine if use of a device to position the tongue forward will decrease the intensity of snoring.

Time Frame

Daily up to 15 days

Title

Frequency of Snoring (Snore Lab App, app records snoring through the night)

Description

To determine if use of a device to position the tongue forward will decrease the frequency of snoring.

Time Frame

Daily up to 15 days

Secondary Outcome Measure Information:

Title

Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)

Description

Evaluate the level of snoring of the subject by bed partner using approved questionnaire

Time Frame

Day 5 (end of no device use)

Title

Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)

Description

Evaluate the level of snoring of the subject by bed partner using approved questionnaire

Time Frame

Day 10 (end of lower device use)

Title

Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)

Description

Evaluate the level of snoring of the subject by bed partner using approved questionnaire

Time Frame

Day 15 (end of lower and upper device use)

Title

Device Tolerance and Comfort (Tolerance Form)

Description

Subject Evaluation of tolerance and comfort of the oral device by questionnaire

Time Frame

Day 5 (end of no device use)

Title

Device Tolerance and Comfort (Tolerance Form)

Description

Subject Evaluation of tolerance and comfort of the oral device by questionnaire

Time Frame

Day 10 (end of lower device use)

Title

Device Tolerance and Comfort (Tolerance Form)

Description

Subject Evaluation of tolerance and comfort of the oral device by questionnaire

Time Frame

Day 15 (end of lower and upper device use)

Title

Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) )

Description

Evaluate the quality of sleep of subject by bed partner by questionnaire

Time Frame

Day 5 (end of no device use)

Title

Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)

Description

Evaluate the quality of sleep of subject by bed partner by questionnaire

Time Frame

Day 10 (end of lower device use)

Title

Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)

Description

Evaluate the quality of sleep of subject by bed partner by questionnaire

Time Frame

Day 15 (end of lower and upper device use)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nancy McDonald, BSN

Phone

502-559-5864

Ext

17787

Nancy.McDonald@nortonhealthcare.org

First Name & Middle Initial & Last Name or Official Title & Degree

David Winslow, MD

Phone

502-559-5864

Ext

17773

David.Winslow@nortonhealthcare.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Winslow, MD

Organizational Affiliation

Norton Healthcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

Norton Clinical Research Group

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40218

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nancy McDonald, BSN

Phone

502-559-5864

Ext

17787

Nancy.McDonald@nortonhealthcare.org

First Name & Middle Initial & Last Name & Degree

David Winslow, MD

Phone

502-559-5864

Ext

17773

David.Winslow@nortonhealthcare.org

First Name & Middle Initial & Last Name & Degree

David H Winslow, MD

First Name & Middle Initial & Last Name & Degree

Kevin K Trice, MD, MBA

First Name & Middle Initial & Last Name & Degree

Stephen W Wyatt, DMD, MPH

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No, this is a limited feasibility study and data will not be generalizable to the public due to small sample size. (n=30)

Citations:

Citation

American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.

Results Reference

background

PubMed Identifier

12117343

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. doi: 10.1001/archotol.128.7.819.

Results Reference

background

Citation

Meira e Cruz M., Cardiovascular Center of University of Lisbon, Lisbon School of Medicine, Lisbon, Portugal; Email: mcruz@medicina.ulisboa.pt

Results Reference

background

PubMed Identifier

16772315

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. doi: 10.1093/ejo/cji122. Epub 2006 Jun 13.

Results Reference

result

PubMed Identifier

24242702

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.

Results Reference

result

PubMed Identifier

11398550

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. doi: 10.1093/ejo/23.2.127.

Results Reference

result

PubMed Identifier

26094920

Citation

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. doi: 10.5664/jcsm.4858.

Results Reference

result

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

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