Evaluating Sleep Quality With Emerging Technologies

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.

NCT Number	NCT06900530
Lead Sponsor	Case Western Reserve University
Conditions	Snoring, Sleep Disturbances, Hypoxia, Obstructive Sleep Apnea (OSA)
Enrollment	52 participants
Start Date	2024-02-10
Primary Completion	2025-12-15 (estimated)
Study Completion	2025-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-01-20