Study to Determine Results of Vibratory Stimulus on Subject's Neck
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Sleep Apnea
- Sponsor
- Kai Medical, Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Head, neck, or jaw movement
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, ages 18 to 80 years old
- •Able to provide written informed consent for themselves and comply with study procedures.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Head, neck, or jaw movement
Time Frame: 1 month
Movement of head, neck, or jaw as evidenced by manual observation and video camera.
Secondary Outcomes
- Affect of sleep stage(1 month)