Study to Determine Results of Vibratory Stimulus on Subject's Neck

Kai Medical

Status and phase: Completed; Phase 1

Conditions: Snoring; Sleep Apnea

Treatments: Device: Kai Strap

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491828

400

Details and patient eligibility

About

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.