A Study of a Neuromodulation Therapy Device for the Treatment of Sleep Apnea

Overview

About this study

The purpose of this study is to test a new device for the treatment of obstructive sleep apnea that delivers an auditory tone to affect neuromodulation while minimizing sleep disturbance.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age 18 years or older
  • Completed a comprehensive Sleep Medicine evaluation and a standard split-night polysomnogram
  • Able to give informed consent
  • Confirmed diagnosis of OSA
  • Positive airway pressure device naive

Exclusion Criteria

  • Unsuccessful CPAP titration
  • Inability to detect screening tone in either ear without the use of hearing aid
  • Inability to tolerate a 37 dB tone
  • Need for nocturnal oxygen or non-invasive positive pressure ventilation due to hypoventilation/hypercapnia
  • Predominantly mixed or central apneas or those who develop complex sleep apnea during the PSG
  • Neurologic disorders such as seizure disorder or narcolepsy
  • Psychiatric disorders currently not under adequate control
  • Need for nurse or other's assistance during the night due to problems of nocturnal confusion, delirium, or other conditions that would preclude the subject from wearing the device all night
  • Pregnancy (will be tested)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

John Park, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20312913

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