Neuromodulation Therapy Device for the Treatment of Sleep Apnea

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01117064

First Posted: May 5, 2010

Last Update Posted: May 29, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Dymedix Corporation

Information provided by (Responsible Party):

John G. Park, Mayo Clinic

Purpose

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.

Condition	Intervention	Phase
Obstructive Sleep Apnea	Device: Neuromodulation Therapy Device (NMTD)	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Neuromodulation Therapy Device for the Treatment of Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by John G. Park, Mayo Clinic:

Primary Outcome Measures:

We will determine effective device settings on the Neuromodulation Therapy Device (NMTD). [ Time Frame: First year ]

Secondary Outcome Measures:

We will compare the modified NMTD's efficacy and tolerability to that of CPAP in treating OSA. [ Time Frame: Second year ]


Enrollment:	18
Study Start Date:	February 2010
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: NMTD adjustment testing We will determine effective NMTD device settings for reducing AHI.	Device: Neuromodulation Therapy Device (NMTD) Subjects will have an overnight PSG using the NMTD. This device detects reduced airflow via a polymer sensor. When such event is detected, a short burst of sound is administered via earphones. We will determine NMTD's operating characteristics for treatment of OSA. The optimal duration of a detected apnea/hypopnea event before NMTD responds must first be determined. Additional adjustable features include sensitivity of respiratory event sensor, as well as pulse duration, frequency, and intensity of the delivered auditory tone. Since independent adjustment of each of the 4 parameters is not feasible, our screening analysis will test two variables at a time to identify which variables most effectively reduce AHI.
Active Comparator: CPAP vs NMTD device We will randomly assign previously titrated CPAP vs. NMTD to each subject then compare the resultant AHI between the two devices.	Device: Neuromodulation Therapy Device (NMTD) Subjects will have an overnight PSG using CPAP (as previously titrated) for half of the night and NMTD the other half (this order will be randomized). we will monitor NMTD's influence on Apnea Hypopnea Index (AHI), sleep architecture, arousal index, and sleep efficiency compared to the same variables during CPAP use
Active Comparator: NMTD efficacy and tolerability Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time.	Device: Neuromodulation Therapy Device (NMTD) Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time.

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Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117064

Locations


United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Dymedix Corporation

Investigators


Principal Investigator:	John G. Park, M.D.	Mayo Clinic

More Information


Responsible Party:	John G. Park, MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01117064 History of Changes
Other Study ID Numbers:	09-006804
First Submitted:	February 8, 2010
First Posted:	May 5, 2010
Last Update Posted:	May 29, 2013
Last Verified:	May 2013

Keywords provided by John G. Park, Mayo Clinic:


Sleep Apnea OSA CPAP

Additional relevant MeSH terms:


Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory	Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases

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