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Hyoid Suspension to the Mandible for the Treatment of Obstructive Sleep Apnea

NCT02738112 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2018-06-27

No results posted yet for this study

Summary

Hyo-mandibular suspension has been previously studied as a treatment for obstructive sleep apnea (OSA) and has shown to be highly effective.

This is a prospective, multi-center, registry during which 30 subjects with OSA will be considered for hyo-mandubular suspension treatment. After obtaining informed consent and meeting all inclusions and exclusion criteria, subjects will be treated using the Encore System. Subject follow-up with the physician or nurse will occur at one (1) week, one (1) month, three (3) months, and twelve (12) months.

This study will assess the effectiveness of hyoid suspension in reducing the apnea-hypopnea index (AHI), and improving the Epworth Sleepiness Scale (ESS), snoring (VAS) and functional outcome (FOSQ) for the treatment of obstructive sleep apnea (OSA). In addition, the study will evaluate the effect that the change in hyoid position has on the airway anatomy.

Conditions

Interventions

DEVICE

Encore System

Hyo-mandibular suspension

Sponsors & Collaborators

  • Abidin, Michael, M.D.

    lead INDIV

Principal Investigators

  • Michael Abidin, MD · Private Practice

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-03-31
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02738112 on ClinicalTrials.gov