Evaluating Sleep Quality With Emerging Technologies

• Conditions: Snoring; Sleep Disturbances; Hypoxia; Obstructive Sleep Apnea (OSA)

• Registration Number: NCT06900530
• Lead Sponsor: Case Western Reserve University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-02-10
• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Between 20 and 75 years of age
• Current orthodontic patient at Case Western Reserve University
• Possession of a smartphone
• Ability to return Belun ring

Exclusion Criteria

• Less than 20 or older than 75 years of age.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal Obstruction Assessment (NOSE) Questionnaire Score	baseline	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.
Adult Obstructive Sleep Apnea (STOPBAng) Questionnaire	baseline	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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire	baseline	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.
Epworth Sleepiness Scale (ESS) Questionnaire	baseline	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.
Belun Ring REM sleep percentage.	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.	The Belun ring measures the the mean REM sleep percentage.
Belun Ring Oxygen Saturation	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.	The Belun ring measures the mean oxygen saturation as the average percentage of oxygen saturation in the blood.
Belun Ring apnea/hypopnea index	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.	The Belun ring measures the apnea/hypopnea index. The outcome is the number of apneic events per hour of sleep.
SleepCycle App	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.	The Sleep Cycle app is a smartphone app that measures time in bed, time asleep, and the presence of snoring.

Trial Locations

Locations (1)

Case Western Reserve University Dental Clinic - Orthodontics; 🇺🇸 Cleveland, Ohio, United States