Study to Determine Results of Vibratory Stimulus on Subject's Neck
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Study to Determine Results of Vibratory Stimulus on Subject's Neck|
- Head, neck, or jaw movement [ Time Frame: 1 month ] [ Designated as safety issue: No ]Movement of head, neck, or jaw as evidenced by manual observation and video camera.
- Affect of sleep stage [ Time Frame: 1 month ] [ Designated as safety issue: No ]Electrocortical arousal caused by device as measured by EEG.
|Study Start Date:||November 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Device: Kai Strap
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491828
|United States, Hawaii|
|Kai Medical Sleep Lab|
|Honolulu, Hawaii, United States, 96816|
|Principal Investigator:||Kelley Ford Shippey III, MD, MS|