Study to Determine Results of Vibratory Stimulus on Subject's Neck
- Conditions
- Sleep ApneaSnoring
- Registration Number
- NCT01491828
- Lead Sponsor
- Kai Medical, Inc.
- Brief Summary
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Male or female, ages 18 to 80 years old
- Able to provide written informed consent for themselves and comply with study procedures.
- Known hyposensitivity or hypersensitivity to vibrations on neck.
- Neurological disorder such as seizure disorder or narcolepsy.
- Psychiatric disorders currently not under control.
- Insomniacs.
- Pregnant women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Head, neck, or jaw movement 1 month Movement of head, neck, or jaw as evidenced by manual observation and video camera.
- Secondary Outcome Measures
Name Time Method Affect of sleep stage 1 month Electrocortical arousal caused by device as measured by EEG.
Trial Locations
- Locations (1)
Kai Medical Sleep Lab
🇺🇸Honolulu, Hawaii, United States