Neuromodulation Therapy Device for the Treatment of Sleep Apnea

NCT01117064 | Completed Phase 1

• 1 other identifier: 09-006804
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea; OSA; CPAP

Outcome Measures

Primary Outcomes (1)

• We will determine effective device settings on the Neuromodulation Therapy Device (NMTD).

  First year

Secondary Outcomes (1)

• We will compare the modified NMTD's efficacy and tolerability to that of CPAP in treating OSA.

  Second year

Study Arms (3)

NMTD adjustment testing

ACTIVE COMPARATOR

We will determine effective NMTD device settings for reducing AHI.

Device: Neuromodulation Therapy Device (NMTD)

CPAP vs NMTD device

ACTIVE COMPARATOR

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)

NMTD efficacy and tolerability

ACTIVE COMPARATOR

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)

Interventions

Neuromodulation Therapy Device (NMTD) DEVICE

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

CPAP vs NMTD device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Mayo Clinic: lead
• Dymedix Corporation: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• John G. Park, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: May 5, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

US (1)