An observational study in Snoring, Sleep Disturbances and Hypoxia, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Case Western Reserve University · Observational
To investigate the sleep quality of the adult orthodontic patient population at the Case Western Reserve University School of Dental Medicine using the NOSE Questionnaire, STOP-BANG Questionnaire, SleepCycle app, and Belun Ring.
The sample will consist of adult orthodontic patients who came seeking care at the Case Western Reserve University School of Dental Medicine's Orthodontic Department.
Inclusion criteria include adult patients in active treatment in the Case Western Reserve University School of Dental Medicine's Orthodontics Department, age 20 or higher, willingness to give informed consent and participate in the study, possession of a smartphone, and ability to return the Belun Ring and complete the follow-up questionnaire. Exclusion criteria include age less than 20, current or history of taking blood pressure medication, pregnancy, hypovolemia, allergy to thermoplastic elastomers or polycarbonates, anemia, use of mandibular repositioning devices, or active palatal expansion.
There were no existing publications similar to our study found in the current literature. So, the required sample size was estimated by the G Power formula for prevalence studies. The global prevalence of AHI 15 was used to estimate the required sample size for this study. The required sample size for 80% power and .05 precision came to 26 subjects.
Patients will complete four questionnaires (STOP-BANG, NOSE Score, Epworth Sleepiness Scale, and PROMIS Sleep Disturbance Questionnaire), and then wear the Belun Ring for 7 consecutive nights and use the Sleep Cycle App for seven consecutive nights. Patients also will complete a sleep tracking journal. Data points collected by the Belun Ring will include start time, end time, total recording time, oxygen desaturation index, total minutes when spO2 higher than 90%, minimum spO2 percentage, percent of time below 90% O2 saturation, mean spO2, sleep efficiency, bAHI, REM sleep (%), mean pulse rate, and total sleep time. The data collected by the Sleep Cycle will include time in bed, time asleep, minutes snoring, sleep regularity, and sleep quality.
The Sleep Cycle app and the Belun Ring will be used used simultaneously. Ideally, all seven night of the week will have data collected. If the patient skips a night of data collection, they will be encouraged to continue the study regardless.
Microsoft Excel will be used for data analysis. The Jarque Bera test will be used to test for the normality of data distribution. Descriptive statistics will be calculated for each category of data from the questionnaires, Belun Ring, and Sleep Cycle app. Correlation analyses will also be performed between all categories of data. One-way Analysis of Variance (ANOVA) tests will be used to assess whether there are significant differences in the data collected each day of the week for the Belun Ring and Sleep Cycle app, at the p=0.05 level of statistical significance. One-way T-tests will be used to compare data between subjects with bAHI less than 10 and bAHI higher than 10.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's enrollment of 52 is below the median of 100 across 22 observational studies indexed under Snoring.
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Adult orthodontic patients
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:
Subjects will be given the NOSE Questionnaire, STOP-BANG Questionnaire, SleepCycle app, and Belun Ring. They will be asked to use the equipment for 7 days and report back
Nasal Obstruction Assessment (NOSE) Questionnaire Score
The NOSE questionnaire is a validated tool that assesses nasal blockage. It provides an objective score that ranges from 0 to 100 with lower scores indicating less nasal blockage and higher scores indicating worse nasal blockage.
Time frame: baseline
Adult Obstructive Sleep Apnea (STOPBAng) Questionnaire
The STOPBang questionnaire is a validated tool that assesses the risk of obstructive sleep apnea (OSA). It provides an objective score that ranges from 0 to 8 with lower scores indicating lower risk of sleep apnea and higher scores indication higher risk of sleep apnea.
Time frame: baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire
The PROMIS Sleep Disturbance Questionnaire assesses the quality of sleep objectively that ranges from 8 to 40 with lower scores indicating less sleep disturbance and higher scores indicating more severe sleep disturbances.
Time frame: baseline
Epworth Sleepiness Scale (ESS) Questionnaire
The Epworth Sleepiness Scale Questionnaire is a validated tool to assess daily sleepiness. It provides an objective score that can range from 0 to 24 with lower scores indicating less daytime sleepiness and higher scores indicating more severe daytime sleepiness.
Time frame: baseline
Belun Ring REM sleep percentage.
The Belun ring measures the the mean REM sleep percentage.
Time frame: The subject is asked to use it for 7 days, and the average and standard deviation of those 7 days is the outcome that will be used.
Belun Ring Oxygen Saturation
The Belun ring measures the mean oxygen saturation as the average percentage of oxygen saturation in the blood.
Time frame: The subject is asked to use it for 7 days, and the average and standard deviation of those 7 days is the outcome that will be used.
Belun Ring apnea/hypopnea index
The Belun ring measures the apnea/hypopnea index. The outcome is the number of apneic events per hour of sleep.
Time frame: The subject is asked to use it for 7 days, and the average and standard deviation of those 7 days is the outcome that will be used.
SleepCycle App
The Sleep Cycle app is a smartphone app that measures time in bed, time asleep, and the presence of snoring.
Time frame: The subject is asked to use it for 7 days, and the average and standard deviation of those 7 days is the outcome that will be used.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data without PHI will be shared upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After study completion
Access criteria: Upon request
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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