Neuromodulation Therapy Device for the Treatment of Sleep Apnea
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ClinicalTrials.gov Identifier: NCT01117064 |
Recruitment Status :
Completed
First Posted : May 5, 2010
Last Update Posted : May 29, 2013
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Condition or disease | Intervention/treatment | Phase |
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Obstructive Sleep Apnea | Device: Neuromodulation Therapy Device (NMTD) | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neuromodulation Therapy Device for the Treatment of Sleep Apnea |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: NMTD adjustment testing
We will determine effective NMTD device settings for reducing AHI.
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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.
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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.
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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. |
- We will determine effective device settings on the Neuromodulation Therapy Device (NMTD). [ Time Frame: First year ]
- We will compare the modified NMTD's efficacy and tolerability to that of CPAP in treating OSA. [ Time Frame: Second year ]

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

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
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | John G. Park, M.D. | Mayo Clinic |
Responsible Party: | John G. Park, MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01117064 |
Other Study ID Numbers: |
09-006804 |
First Posted: | May 5, 2010 Key Record Dates |
Last Update Posted: | May 29, 2013 |
Last Verified: | May 2013 |
Sleep Apnea OSA CPAP |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |