SnoringNCT04900285
Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
A study testing Delta Dental Oral Device in people with Snoring, run by Norton Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- Delta Dental Oral Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . 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-
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Norton Clinical Research Group
Louisville, Kentucky, 40218
Nancy McDonald, BSN, 502-559-5864 ext. 17787, Nancy.McDonald@nortonhealthcare.org
David Winslow, MD, 502-559-5864 ext. 17773, David.Winslow@nortonhealthcare.org
About this study
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.
Read the 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.
- Conditions
- Snoring
- Being tested
- Delta Dental Oral Device
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta Dental Oral DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dental Device Arm | Other | 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. Receives: Device: Delta Dental Oral Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily up to 15 days
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.
Measured: Daily up to 15 days
Secondary outcomes (9)
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
Measured: Day 5 (end of no device use)
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
Measured: Day 10 (end of lower device use)
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
Measured: Day 15 (end of lower and upper device use)
Device Tolerance and Comfort (Tolerance Form)
Subject Evaluation of tolerance and comfort of the oral device by questionnaire
Measured: Day 5 (end of no device use)
Device Tolerance and Comfort (Tolerance Form)
Subject Evaluation of tolerance and comfort of the oral device by questionnaire
Measured: Day 10 (end of lower device use)
Device Tolerance and Comfort (Tolerance Form)
Subject Evaluation of tolerance and comfort of the oral device by questionnaire
Measured: Day 15 (end of lower and upper device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) )
Evaluate the quality of sleep of subject by bed partner by questionnaire
Measured: Day 5 (end of no device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)
Evaluate the quality of sleep of subject by bed partner by questionnaire
Measured: Day 10 (end of lower device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)
Evaluate the quality of sleep of subject by bed partner by questionnaire
Measured: Day 15 (end of lower and upper device use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norton Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Delta Dental Foundation
- Responsible party
- Principal investigator, David Winslow, Jr., MD, FCCP, Norton Healthcare
- Investigators
- David Winslow, MD, Principal investigator, Norton Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900285
- Sponsor's protocol ID
- 20-N0387
- Status last verified
- Apr 2022
- First submitted
- 13 May 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No, this is a limited feasibility study and data will not be generalizable to the public due to small sample size. (n=30)
Publications
American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
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.
PubMed 12117343Meira e Cruz M., Cardiovascular Center of University of Lisbon, Lisbon School of Medicine, Lisbon, Portugal; Email: mcruz@medicina.ulisboa.pt
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.
PubMed 16772315Deeb 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.
PubMed 24242702Johnston 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.
PubMed 11398550Ramar 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.
PubMed 26094920
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
- ClinicalTrials.gov ID
- NCT04900285
- Acronym / sponsor ID
- 20-N0387
- Conditions
- Snoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Norton HealthcareUniversity, hospital or other
- Collaborators
- Delta Dental Foundation
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dental Device Arm | Other | Device: Delta Dental Oral DeviceSubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . 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-
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delta Dental Oral DeviceThe 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. | Device | Dental Device Arm |
Primary outcome
Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome)
Time frame: Daily up to 15 days
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)
Time frame: Daily up to 15 days
To determine if use of a device to position the tongue forward will decrease the frequency of snoring.
9 secondary outcomes
Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)
Time frame: Day 5 (end of no device use)
Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)
Time frame: Day 10 (end of lower device use)
Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)
Time frame: Day 15 (end of lower and upper device use)
Device Tolerance and Comfort (Tolerance Form)
Time frame: Day 5 (end of no device use)
Device Tolerance and Comfort (Tolerance Form)
Time frame: Day 10 (end of lower device use)
Device Tolerance and Comfort (Tolerance Form)
Time frame: Day 15 (end of lower and upper device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) )
Time frame: Day 5 (end of no device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)
Time frame: Day 10 (end of lower device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)
Time frame: Day 15 (end of lower and upper device use)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- BackgroundAmerican Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
- Background: PubMed 12117343Gliklich 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.
- BackgroundMeira e Cruz M., Cardiovascular Center of University of Lisbon, Lisbon School of Medicine, Lisbon, Portugal; Email: mcruz@medicina.ulisboa.pt
- Results publication: PubMed 16772315Cooke 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 publication: PubMed 24242702Deeb 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 publication: PubMed 11398550Johnston 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 publication: PubMed 26094920Ramar 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.
- Individual participant dataSharing planned: No. No, this is a limited feasibility study and data will not be generalizable to the public due to small sample size. (n=30)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Winslow, MD principal investigator
Norton Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delta Dental Oral Device in people with Snoring, run by Norton Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy McDonald, BSN (502-559-5864 ext. 17787, Nancy.McDonald@nortonhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome) (time frame: Daily up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900285, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.