Clinical trial NCT06900530: Evaluating Sleep Quality With Emerging Technologies
Official title: Evaluating Sleep Quality With Emerging Technologies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Snoring
Sleep Disturbances
Hypoxia
Obstructive Sleep Apnea (OSA)
Keywords: Sleep quality
AHI
OSA
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult orthodontic patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nasal Obstruction Assessment (NOSE) Questionnaire Score
timeFrame: baseline
measure: Adult Obstructive Sleep Apnea (STOPBAng) Questionnaire
timeFrame: baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Questionnaire
timeFrame: baseline
measure: Epworth Sleepiness Scale (ESS) Questionnaire
timeFrame: baseline
measure: Belun Ring REM sleep percentage.
timeFrame: 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.
measure: Belun Ring Oxygen Saturation
timeFrame: 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.
measure: Belun Ring apnea/hypopnea index
timeFrame: 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.
measure: SleepCycle App
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University Dental Clinic - Orthodontics
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Juan M Palomo, DDS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Yeh E, Wong E, Tsai CW, Gu W, Chen PL, Leung L, Wu IC, Strohl KP, Folz RJ, Yar W, Chiang AA. Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network-based algorithm and its combined use with STOP-Bang questionnaire. PLoS One. 2021 Oct 11;16(10):e0258040. doi: 10.1371/journal.pone.0258040. eCollection 2021.
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citation: Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.
citation: Klaus K, Stummer AL, Ruf S. Accuracy of a Smartphone Application Measuring Snoring in Adults-How Smart Is It Actually? Int J Environ Res Public Health. 2021 Jul 8;18(14):7326. doi: 10.3390/ijerph18147326.
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