Evaluating Sleep Quality With Emerging Technologies

January 16, 2026 updated by: Case Western Reserve University

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University Dental Clinic - Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult orthodontic patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Experimental
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Investigators

  • Principal Investigator: Juan M Palomo, DDS, MSD, Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2024

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20221147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data without PHI will be shared upon request.

IPD Sharing Time Frame

After study completion

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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