An interventional study of Delta Dental Oral Device in Snoring, sponsored by Norton Healthcare. Status unknown at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Norton Healthcare · Not applicable, Interventional, and Prevention
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.
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's planned enrollment of 30 is below the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →Norton Healthcare is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
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.
Time frame: 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.
Time frame: Daily up to 15 days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 15 (end of lower and upper device use)
Plan to share: No — No, this is a limited feasibility study and data will not be generalizable to the public due to small sample size. (n=30)
Started Jun 2021 (actual). Primary completion is estimated for Dec 2023, 30 months after the start.
Of 33 non-industry interventional studies with no phase under Snoring, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 31. This study's planned 30 months is above that.
Counting every sponsor, half of 45 studies reached it within 20 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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