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Search / Trial NCT06900530

Evaluating Sleep Quality With Emerging Technologies

Launched by CASE WESTERN RESERVE UNIVERSITY · Mar 21, 2025

Trial Information

Current as of September 16, 2025

Enrolling by invitation

Keywords

Sleep Quality Ahi Osa

ClinConnect Summary

This is an observational study at Case Western Reserve University to learn more about sleep quality in adult orthodontic patients using new tech. Researchers will gather four sleep questionnaires (NOSE for nasal blockage, STOP-BANG for sleep apnea risk, Epworth Sleepiness Scale for daytime sleepiness, and PROMIS Sleep Disturbance), plus data from a Belun Ring worn for seven nights and the Sleep Cycle phone app. The goal is to see how these tools work together to capture sleep quality and breathing during sleep.

Eligible participants are adults aged 20 to 75 who are currently receiving orthodontic care at the university, have a smartphone, and can wear and return the Belun Ring. Exclusions include being younger than 20 or older than 75, pregnancy, certain medical conditions or medications (like blood pressure drugs), anemia, hypovolemia, allergy to the ring materials, and not using certain dental appliances. Participants will complete baseline questionnaires, wear the ring and use the Sleep Cycle app for seven consecutive nights, and keep a simple sleep journal. The study is still enrolling by invitation, with results not yet available, and any shared data will be de-identified after study completion if requested.

Gender

ALL

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.

About Case Western Reserve University

Case Western Reserve University (CWRU) is a leading research institution located in Cleveland, Ohio, renowned for its commitment to advancing knowledge and improving health outcomes through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, CWRU integrates expertise from various fields, including medicine, engineering, and social sciences, to address complex health challenges. The university's clinical trial initiatives are designed to foster the development of novel therapies and interventions, ensuring rigorous scientific methodologies and ethical standards are upheld. CWRU is dedicated to translating research findings into tangible benefits for patients and communities, contributing significantly to the advancement of healthcare practices and policies.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Juan M Palomo, DDS, MSD

Principal Investigator

Case Western Reserve University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported