Neuromodulation Therapy Device for the Treatment of Sleep Apnea
Completed · Phase 1
Conditions studied: Obstructive Sleep Apnea
In brief
We are looking to test a novel device in the treatment of Obstructive Sleep Apnea (OSA). Rather than using positive pressure to open the airways, we are testing a device that delivers an auditory tone to affect neuromodulation. We will test its efficacy in treating OSA while minimizing sleep disturbance. As this device is much less cumbersome to wear, we hope this therapy device will also improve compliance with treatment.
Key facts
- Study ID
- NCT01117064
- Run by
- Mayo Clinic
- People needed
- 18
- Starts
- 2010-02-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2013-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects 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
You may not qualify if…
- 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)
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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