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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sleep Apnea Snoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Kai Strap

Medical device component that vibrates on a subject's neck.

Intervention Type DEVICE

Other Intervention Names

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Kai Patch

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes