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

March 19, 2012 updated by: Kai Medical, Inc.
This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Kai Medical Sleep Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Head, neck, or jaw movement
Time Frame: 1 month
Movement of head, neck, or jaw as evidenced by manual observation and video camera.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Affect of sleep stage
Time Frame: 1 month
Electrocortical arousal caused by device as measured by EEG.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kai Medical, Inc.

Investigators

  • Principal Investigator: Kelley Ford Shippey III, MD, MS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 10, 2011

First Submitted That Met QC Criteria

December 13, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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