Evaluating Sleep Quality With Emerging Technologies

NCT06900530 | Completed

• 1 other identifier: STUDY20221147
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Snoring; Sleep Disturbances; Hypoxia; Obstructive Sleep Apnea (OSA)

Keywords

Sleep quality; AHI; OSA

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  baseline

• Belun Ring REM sleep percentage.

  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

  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

  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

  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.

Study Arms (1)

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult orthodontic patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University Dental Clinic - Orthodontics

Cleveland, Ohio, 44106, United States

Location

Related Publications (7)

• Schutte-Rodin S, Deak MC, Khosla S, Goldstein CA, Yurcheshen M, Chiang A, Gault D, Kern J, O'Hearn D, Ryals S, Verma N, Kirsch DB, Baron K, Holfinger S, Miller J, Patel R, Bhargava S, Ramar K. Evaluating consumer and clinical sleep technologies: an American Academy of Sleep Medicine update. J Clin Sleep Med. 2021 Nov 1;17(11):2275-2282. doi: 10.5664/jcsm.9580. No abstract available.

  PMID: 34314344 BACKGROUND

• 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.

  PMID: 34634070 BACKGROUND

• Gu W, Leung L, Kwok KC, Wu IC, Folz RJ, Chiang AA. Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea. J Clin Sleep Med. 2020 Sep 15;16(9):1611-1617. doi: 10.5664/jcsm.8592.

  PMID: 32464087 BACKGROUND

• Nagappa M, Liao P, Wong J, Auckley D, Ramachandran SK, Memtsoudis S, Mokhlesi B, Chung F. Validation of the STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea among Different Populations: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 14;10(12):e0143697. doi: 10.1371/journal.pone.0143697. eCollection 2015.

  PMID: 26658438 BACKGROUND

• 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.

  PMID: 26378880 BACKGROUND

• 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.

  PMID: 34299777 BACKGROUND

• Figueras-Alvarez O, Canto-Naves O, Cabratosa-Termes J, Roig-Cayon M, Felipe-Spada N, Tomas-Aliberas J. Snoring intensity assessment with three different smartphones using the SnoreLab application in one participant. J Clin Sleep Med. 2020 Nov 15;16(11):1971-1974. doi: 10.5664/jcsm.8676.

  PMID: 32638700 BACKGROUND

MeSH Terms

Conditions

Snoring; Parasomnias; Hypoxia; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Juan M Palomo, DDS, MSD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 28, 2025
• Study Start: February 10, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After study completion
• Access Criteria: Upon request

Locations

US (1)