Sleep Apnea, Snoring
Conditions
Keywords
Apnea, Sleep apnea, Snoring, Hypoglossal nerve stimulation, Laynx stimulation
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.
Interventions
DEVICEKai Strap
Medical device component that vibrates on a subject's neck.
Sponsors
Kai Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Head, neck, or jaw movement | 1 month | Movement of head, neck, or jaw as evidenced by manual observation and video camera. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Affect of sleep stage | 1 month | Electrocortical arousal caused by device as measured by EEG. |
Countries
United States
Outcome results
None listed