Recruiting

Oral Appliance

Sponsor:

Norton Healthcare

Code:

NCT04900285

Conditions

Snoring

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Delta Dental Oral Device

Study Details

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.

Conditions

Snoring

Study ID

NCT04900285

Start date

Jun 1, 2021

Status verified date

Apr, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Dental Device Arm

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.

Interventions

Delta Dental Oral Device

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

  • Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome) [ Time Frame: Daily up to 15 days ]
  • Frequency of Snoring (Snore Lab App, app records snoring through the night) [ Time Frame: Daily up to 15 days ]

Central Contacts and Locations

Central contacts

Nancy McDonald, BSN

502-559-5864Nancy.McDonald@nortonhealthcare.org

David Winslow, MD

502-559-5864David.Winslow@nortonhealthcare.org

Locations

Norton Clinical Research Group

Recruiting

Louisville, Kentucky, United States, 40218

Contacts

Nancy McDonald, BSN

502-559-5864Nancy.McDonald@nortonhealthcare.org

David Winslow, MD

502-559-5864David.Winslow@nortonhealthcare.org

Principal Investigator:

David H Winslow, MD

More Information

Sponsor

Norton Healthcare

Last update posted

Apr 6, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Norton Healthcare on 2022-04-06.