Neuromodulation Therapy Device for the Treatment of Sleep Apnea

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Obstructive Sleep Apnea
Interventions
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

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.

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.

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Dymedix Corporation

INDUSTRY

lead

Mayo Clinic

OTHER